Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008975
Company: ANI PHARMS

Products on NDA 008975

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PURIFIED CORTROPHIN GEL	CORTICOTROPIN	40 UNITS/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
PURIFIED CORTROPHIN GEL	CORTICOTROPIN	80 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008975

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/1954	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008975s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/008975Orig1s012ltr.pdf
10/29/2021	SUPPL-8	Manufacturing (CMC)-Packaging	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/008975Orig1s008.pdf
12/08/1977	SUPPL-6	Labeling		Label is not available on this site.
05/25/1977	SUPPL-5	Labeling		Label is not available on this site.

Labels for NDA 008975

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008975s012lbl.pdf