LABELS · 386130d4-1b0d-5e87-e063-6394a90aefa7

Steritalc 2g

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: 2025-06-25
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1.INDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax. ___________ INDICATIONS AND USAGE__ __________ STERITALC® is a sclerosing agent indicated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1.1) In adults to decrease the recurrence of pneumothorax. (1.2)

Full extracted label fields

application numbers

NDA205555

boxed warning exact

brand names

Steritalc 2g
Steritalc 3g
Steritalc 4g

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c94e51d9-beef-4b06-e053-2a95a90a754a

generic names

TALC

386130d4-1b0d-5e87-e063-6394a90aefa7

indications and usage exact

1.INDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax. ___________ INDICATIONS AND USAGE__ __________ STERITALC® is a sclerosing agent indicated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1.1) In adults to decrease the recurrence of pneumothorax. (1.2)

indications and usage tables exact

is original packager

true

manufacturer names

Novatech SA

matched search terms

malignant

package ndcs

62327-444-04
62327-444-44
62327-222-02
62327-222-42
62327-333-03
62327-333-43

product ndcs

62327-222
62327-444
62327-333

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

5.4 Asbestos Content Talc products may contain trace amounts of asbestos. Asbestos is a known human carcinogen. Exposure to asbestos may increase the risk of mesotheliomas and other cancers including lung, larynx, and ovarian cancer. STERITALC is tested for asbestos and asbestiform fibers [see DESCRIPTION (11)]. Warnings and Precautions (5.4) 06/2025

record type

complete_spl_indications_section_candidate

routes

INTRAPLEURAL

rxcuis

2003393
2003398
2003400
2003402
2003403
2003405

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.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: 200
total: 830

terms

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

sha256

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url

source url

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spl effective date

2025-06-25

spl effective time

20250625

spl set id

c94e51d9-beef-4b06-e053-2a95a90a754a

spl version

substance names

TALC

uniis

7SEV7J4R1U

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
NDA205555
payload
all indexed label documents
Appl No
205555
Application Docs Date
2017-05-04 00:00:00
Application Docs ID
48236
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205555s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
205555
Application Docs Date
2025-06-11 00:00:00
Application Docs ID
82532
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205555s005lbl.pdf
Submission No
5
Submission Type
SUPPL
all submission records
Appl No
205555
Review Priority
STANDARD
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2017-05-01 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
205555
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
2025-06-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA205555
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=205555
has approved submission record
true
latest approved submission date
2025-06-10
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
205555
Application Docs Date
2025-06-11 00:00:00
Application Docs ID
82532
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205555s005lbl.pdf
Submission No
5
Submission Type
SUPPL
official application record
Appl No
205555
Appl Public Notes
Appl Type
NDA
Sponsor Name
NOVATECH SA
openfda application present
true
products
Active Ingredient
TALC
Appl No
205555
Drug Name
STERITALC
Form
POWDER;INTRAPLEURAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
2GM/VIAL
marketing status
Prescription
Active Ingredient
TALC
Appl No
205555
Drug Name
STERITALC
Form
POWDER;INTRAPLEURAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
3GM/VIAL
marketing status
Prescription
Active Ingredient
TALC
Appl No
205555
Drug Name
STERITALC
Form
POWDER;INTRAPLEURAL
Product No
003
Reference Drug
1
Reference Standard
1
Strength
4GM/VIAL
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 · unclassified context

application numbers

NDA205555

brand names

Steritalc 2g
Steritalc 3g
Steritalc 4g

classification reasons

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clinical review status

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source url

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spl effective date

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spl set id

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

use intent

unclear

Passage 2 · positive indication candidate

application numbers

NDA205555

brand names

Steritalc 2g
Steritalc 3g
Steritalc 4g

classification reasons

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no_tumor_directed_keyword_in_positive_statement

clinical review status

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content role

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context span

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source defined aliases

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exact text: 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.
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source url

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spl effective date

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spl set id

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spl version

structured fields status

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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 3 · positive indication candidate

application numbers

NDA205555

brand names

Steritalc 2g
Steritalc 3g
Steritalc 4g

classification reasons

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no_tumor_directed_keyword_in_positive_statement

clinical review status

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content role

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context span

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exact text: S AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax. ___________ INDICATIONS AND USAGE__ __________ STERITALC® is a sclerosing agent indicated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1.1) In adults to decrease the recurrence of pneumothorax. (1.2)
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dup-4c7b958a1d71a127dd5c

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label id

386130d4-1b0d-5e87-e063-6394a90aefa7

positive predicate support span

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qualifier mentions

context exact
1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax. ___________ IND
kind
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source url

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spl effective date

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spl set id

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spl version

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structured indication

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approval pathway: Source null
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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 4 · unclassified context

application numbers

NDA205555

brand names

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Steritalc 3g
Steritalc 4g

classification reasons

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clinical review status

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content role

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source url

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spl effective date

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tumor histology: Source null

use intent

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Passage 5 · positive indication candidate

application numbers

NDA205555

brand names

Steritalc 2g
Steritalc 3g
Steritalc 4g

classification reasons

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prior therapy: Source null
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tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 6 · unclassified context

application numbers

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brand names

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Steritalc 3g
Steritalc 4g

classification reasons

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clinical review status

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content role

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exact text: ated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1.1) In adults to decrease the recurrence of pneumothorax. (1.2)
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source url

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

use intent

unclear

Preserved source evidence · Not medical advice