LABELS · 4c20479c-d75a-a0c7-e063-6394a90a9e59

Ethyol

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-03-03
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1 , 5.1 , 5.2 ) 1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1) ] . 1.2 Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see Clinical Studies (14.2) ] . Limitation of Use Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure [see Warnings and Precautions (5.1) ] , or in patients receiving definitive radiotherapy [see Warnings and Precautions (5.2) ] , except in the context of a clinical study.

Full extracted label fields

application numbers

NDA020221

boxed warning exact

brand names

Ethyol

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a17563f2-d231-4385-bc94-0217be78b89d

generic names

AMIFOSTINE

4c20479c-d75a-a0c7-e063-6394a90a9e59

indications and usage exact

1 INDICATIONS AND USAGE ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1 , 5.1 , 5.2 ) 1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1) ] . 1.2 Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see Clinical Studies (14.2) ] . Limitation of Use Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure [see Warnings and Precautions (5.1) ] , or in patients receiving definitive radiotherapy [see Warnings and Precautions (5.2) ] , except in the context of a clinical study.

indications and usage tables exact

is original packager

true

manufacturer names

Legacy Pharma USA Inc.

matched search terms

cancer

package ndcs

83107-030-01
83107-030-02

product ndcs

83107-030

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

308096
1803018

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 300
total: 830

terms

https://open.fda.gov/terms/

sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%224c20479c-d75a-a0c7-e063-6394a90a9e59%22

spl effective date

2026-03-03

spl effective time

20260303

spl set id

a17563f2-d231-4385-bc94-0217be78b89d

spl version

substance names

AMIFOSTINE

uniis

M487QF2F4V

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA020221
payload
all indexed label documents
Appl No
020221
Application Docs Date
2008-11-12 00:00:00
Application Docs ID
12329
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf
Submission No
24
Submission Type
SUPPL
Appl No
020221
Application Docs Date
1999-06-24 00:00:00
Application Docs ID
34387
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20221s12lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
020221
Application Docs Date
2003-03-28 00:00:00
Application Docs ID
34388
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20221slr017_ethyol_lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
020221
Application Docs Date
2016-12-19 00:00:00
Application Docs ID
46217
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020221s032lbl.pdf
Submission No
32
Submission Type
SUPPL
Appl No
020221
Application Docs Date
2017-05-30 00:00:00
Application Docs ID
48557
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020221s033lbl.pdf
Submission No
33
Submission Type
SUPPL
Appl No
020221
Application Docs Date
2019-07-30 00:00:00
Application Docs ID
59500
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020221s036lbl.pdf
Submission No
36
Submission Type
SUPPL
all submission records
Appl No
020221
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
36
Submission Status
AP
Submission Status Date
2019-07-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
33
Submission Status
AP
Submission Status Date
2017-05-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
32
Submission Status
AP
Submission Status Date
2016-12-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
31
Submission Status
AP
Submission Status Date
2016-01-15 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
30
Submission Status
AP
Submission Status Date
2016-03-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
28
Submission Status
AP
Submission Status Date
2013-08-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
24
Submission Status
AP
Submission Status Date
2008-11-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
20
Submission Status
AP
Submission Status Date
2006-03-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
17
Submission Status
AP
Submission Status Date
2003-03-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
15
Submission Status
AP
Submission Status Date
2002-02-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
14
Submission Status
AP
Submission Status Date
1999-09-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020221
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
1999-04-01 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA020221
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020221
has approved submission record
true
latest approved submission date
2019-07-25
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
020221
Application Docs Date
2019-07-30 00:00:00
Application Docs ID
59500
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020221s036lbl.pdf
Submission No
36
Submission Type
SUPPL
official application record
Appl No
020221
Appl Public Notes
Appl Type
NDA
Sponsor Name
LEGACY
openfda application present
true
products
Active Ingredient
AMIFOSTINE
Appl No
020221
Drug Name
ETHYOL
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
1
Reference Standard
1
Strength
500MG/VIAL
marketing status
Prescription
Active Ingredient
AMIFOSTINE
Appl No
020221
Drug Name
ETHYOL
Form
INJECTABLE;INJECTION
Product No
002
Reference Drug
0
Reference Standard
0
Strength
375MG/VIAL
marketing status
Discontinued

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA020221

brand names

Ethyol

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement
positive_statement_also_contains_qualification_review_required

clinical review status

pending

content role

positive_indication_candidate

context span

end: 407
end exclusive: true
exact text: 1 INDICATIONS AND USAGE ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substanti
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current approval status

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extraction review status

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generic names

AMIFOSTINE

ind-span-8bc822711a789c6f8f19

label id

4c20479c-d75a-a0c7-e063-6394a90a9e59

positive predicate support span

end: 66
end exclusive: true
exact text: is a cytoprotective agent indicated
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source array index: 0
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source text sha256: 2ae496510cfe25e680d4f29d16a2ba28597195f8205c00a61b1ce70d55db7b66
start: 31

qualifier mentions

context exact
with repeated administration of cisplatin in patients with advanced ovarian cancer.
kind
stage_or_setting
polarity
not_inferred
span
end
206
end exclusive
true
exact text
advanced ovarian cancer
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source text sha256
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start
183

regulatory links

schema version

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source batch sha256

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source defined aliases

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end exclusive: true
exact text: 1 INDICATIONS AND USAGE ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 2ae496510cfe25e680d4f29d16a2ba28597195f8205c00a61b1ce70d55db7b66
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%224c20479c-d75a-a0c7-e063-6394a90a9e59%22

spl effective date

2026-03-03

spl set id

a17563f2-d231-4385-bc94-0217be78b89d

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

NDA020221

brand names

Ethyol

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 640
end exclusive: true
exact text: TIONS AND USAGE ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1 , 5.1 , 5.2
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source text sha256: 2ae496510cfe25e680d4f29d16a2ba28597195f8205c00a61b1ce70d55db7b66
start: 8

current approval status

not_reconciled

duplicate text group

dup-583397fd09f5478aa2b2

extraction review status

automated_candidate_pending_source_review

generic names

AMIFOSTINE

ind-span-3529324d78be67223ddb

label id

4c20479c-d75a-a0c7-e063-6394a90a9e59

positive predicate support span

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qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

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end: 440
end exclusive: true
exact text: ( 1.1 ) – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.
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offset unit: unicode_code_points
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source text sha256: 2ae496510cfe25e680d4f29d16a2ba28597195f8205c00a61b1ce70d55db7b66
start: 208

source url

https://api.fda.gov/drug/label.json?search=id%3A%224c20479c-d75a-a0c7-e063-6394a90a9e59%22

spl effective date

2026-03-03

spl set id

a17563f2-d231-4385-bc94-0217be78b89d

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · unclassified context

application numbers

NDA020221

brand names

Ethyol

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 823
end exclusive: true
exact text: nce of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1 , 5.1 , 5.2 ) 1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisp
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current approval status

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duplicate text group

dup-cd77b0d8843ed6c1ca54

extraction review status

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generic names

AMIFOSTINE

ind-span-8c3d06656ddaa6768859

label id

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positive predicate support span

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schema version

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source batch sha256

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source defined aliases

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exact text: ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%224c20479c-d75a-a0c7-e063-6394a90a9e59%22

spl effective date

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spl set id

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spl version

structured fields status

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

application numbers

NDA020221

brand names

Ethyol

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 841
end exclusive: true
exact text: parotid glands. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1 , 5.1 , 5.2 ) 1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients
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exact text: ( 1 , 5.1 , 5.2 )
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source url

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spl effective date

2026-03-03

spl set id

a17563f2-d231-4385-bc94-0217be78b89d

spl version

structured fields status

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · positive indication candidate

application numbers

NDA020221

brand names

Ethyol

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement
positive_statement_also_contains_qualification_review_required

clinical review status

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content role

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context span

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end exclusive: true
exact text: 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1 , 5.1 , 5.2 ) 1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1) ] . 1.2 Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative r
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source array index: 0
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current approval status

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generic names

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positive predicate support span

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qualifier mentions

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exact text
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exact text: 1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1) ] .
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exact text: ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1) ] . 1.2 Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see Clinical Studies (14.2) ] . Limitation of Use Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure [see Warnings and Precautions (5.1) ] , or in patients receiving definitive
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exact text: 1.2 Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see Clinical Studies (14.2) ] .
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Preserved source evidence · Not medical advice