LABELS · 0ce07394-417b-4592-a051-8d63bdafbada

Synarel

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: 2026-03-05
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH. Pelvic ultrasound assessment in girls usually reveals enlarged uterus and ovaries, the latter often with multiple cystic formations. Magnetic resonance imaging or CT-scanning of the brain is recommended to detect hypothalamic or pituitary tumors, or anatomical changes associated with increased intracranial pressure. Other causes of sexual precocity, such as congenital adrenal hyperplasia, testotoxicosis, testicular tumors and/or other autonomous feminizing or masculinizing disorders must be excluded by proper clinical hormonal and diagnostic imaging examinations.
INDICATIONS AND USAGE FOR ENDOMETRIOSIS (For Central Precocious Puberty, See Reverse Side ) SYNAREL is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Experience with SYNAREL for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.

Full extracted label fields

application numbers

NDA019886

boxed warning exact

brand names

Synarel

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6

generic names

NAFARELIN ACETATE

0ce07394-417b-4592-a051-8d63bdafbada

indications and usage exact

INDICATIONS AND USAGE FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH. Pelvic ultrasound assessment in girls usually reveals enlarged uterus and ovaries, the latter often with multiple cystic formations. Magnetic resonance imaging or CT-scanning of the brain is recommended to detect hypothalamic or pituitary tumors, or anatomical changes associated with increased intracranial pressure. Other causes of sexual precocity, such as congenital adrenal hyperplasia, testotoxicosis, testicular tumors and/or other autonomous feminizing or masculinizing disorders must be excluded by proper clinical hormonal and diagnostic imaging examinations.
INDICATIONS AND USAGE FOR ENDOMETRIOSIS (For Central Precocious Puberty, See Reverse Side ) SYNAREL is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Experience with SYNAREL for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.

indications and usage tables exact

is original packager

true

manufacturer names

Pfizer Laboratories Div Pfizer Inc

matched search terms

tumors

package ndcs

0025-0166-08

product ndcs

0025-0166

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

NASAL

rxcuis

1797878
1797880

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.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: 0
total: 830

terms

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

sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%220ce07394-417b-4592-a051-8d63bdafbada%22

spl effective date

2026-03-05

spl effective time

20260305

spl set id

d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6

spl version

substance names

NAFARELIN ACETATE

uniis

8ENZ0QJW4H

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
NDA019886
payload
all indexed label documents
Appl No
019886
Application Docs Date
2011-01-11 00:00:00
Application Docs ID
11813
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf
Submission No
26
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2015-08-10 00:00:00
Application Docs ID
11814
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019886s032lbl.pdf
Submission No
32
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2006-04-13 00:00:00
Application Docs ID
34066
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019886s022lbl.pdf
Submission No
22
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2011-01-11 00:00:00
Application Docs ID
34067
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf
Submission No
27
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2012-01-12 00:00:00
Application Docs ID
34068
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019886s030lbl.pdf
Submission No
30
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2017-05-22 00:00:00
Application Docs ID
48477
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf
Submission No
33
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2017-05-22 00:00:00
Application Docs ID
48478
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf
Submission No
35
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2022-04-27 00:00:00
Application Docs ID
70830
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019886s038lbl.pdf
Submission No
38
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2023-02-07 00:00:00
Application Docs ID
73402
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019886s039lbl.pdf
Submission No
39
Submission Type
SUPPL
Appl No
019886
Application Docs Date
2025-11-25 00:00:00
Application Docs ID
84302
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019886s040lbl.pdf
Submission No
40
Submission Type
SUPPL
all submission records
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
40
Submission Status
AP
Submission Status Date
2025-11-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
39
Submission Status
AP
Submission Status Date
2023-01-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
38
Submission Status
AP
Submission Status Date
2022-04-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
35
Submission Status
AP
Submission Status Date
2017-05-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
33
Submission Status
AP
Submission Status Date
2017-05-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
32
Submission Status
AP
Submission Status Date
2015-08-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
31
Submission Status
AP
Submission Status Date
2014-03-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
30
Submission Status
AP
Submission Status Date
2012-01-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
27
Submission Status
AP
Submission Status Date
2011-01-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
26
Submission Status
AP
Submission Status Date
2011-01-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
22
Submission Status
AP
Submission Status Date
2006-04-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
019886
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
21
Submission Status
AP
Submission Status Date
2002-06-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA019886
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=019886
has approved submission record
true
latest approved submission date
2025-11-24
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
019886
Application Docs Date
2025-11-25 00:00:00
Application Docs ID
84302
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019886s040lbl.pdf
Submission No
40
Submission Type
SUPPL
official application record
Appl No
019886
Appl Public Notes
Appl Type
NDA
Sponsor Name
PFIZER
openfda application present
true
products
Active Ingredient
NAFARELIN ACETATE
Appl No
019886
Drug Name
SYNAREL
Form
SPRAY, METERED;NASAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 0.2MG BASE/SPRAY
marketing status
Prescription

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

NDA019886

brand names

Synarel

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 433
end exclusive: true
exact text: INDICATIONS AND USAGE FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and
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current approval status

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generic names

NAFARELIN ACETATE

ind-span-79eff2bbbc308329f16a

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exact text: is indicated
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qualifier mentions

context exact
uberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes.
kind
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exact text: INDICATIONS AND USAGE FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes.
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source url

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spl effective date

2026-03-05

spl set id

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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

non_oncology_or_unclear_candidate

Passage 2 · unclassified context

application numbers

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brand names

Synarel

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

unclassified_context

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exact text: PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH. Pelvic ultrasound assessment in girls usually reveals enlarged uteru
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dup-64b62cd8776e10722929

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generic names

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ind-span-6dce8be722914ec5f6ec

label id

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positive predicate support span

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qualifier mentions

context exact
ndary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by signifi
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exact text: The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction.
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source url

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spl effective date

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limitations: Source null
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tumor histology: Source null

use intent

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Passage 3 · unclassified context

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exact text: secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH. Pelvic ultrasound assessment in girls usually reveals enlarged uterus and ovaries, the latter often with multiple cystic formations. Magnetic resonance imaging or CT-scanning of the brain is recommen
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exact text: The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH.
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source url

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structured indication

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limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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Passage 4 · unclassified context

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exact text: icant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH. Pelvic ultrasound assessment in girls usually reveals enlarged uterus and ovaries, the latter often with multiple cystic formations. Magnetic resonance imaging or CT-scanning of the brain is recommended to detect hypothalamic or pituitary tumors, or anatomical changes associated with increased intracranial pressure. Other causes o
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