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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012015
Company: EPIC PHARMA LLC

Products on NDA 012015

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COGENTIN	BENZTROPINE MESYLATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012015

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/1959	ORIG-1	Approval	Type 3 - New Dosage Form	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
08/06/2022	SUPPL-36	Manufacturing (CMC)-Manufacturing Process	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/005939Orig1s012;011525Orig1s031;012015Orig1s036;016619Orig1s045;019353Orig1s024;208609Orig1s006correctedltr.pdf
02/03/2015	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
06/26/2013	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
04/22/2013	SUPPL-27	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf
04/22/2013	SUPPL-26	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf
07/27/1998	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
07/24/1998	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
05/22/2001	SUPPL-23	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf
04/15/1996	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/26/1996	SUPPL-21	Labeling		Label is not available on this site.
10/31/1988	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
01/14/1986	SUPPL-18	Labeling		Label is not available on this site.
11/02/1981	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/19/1981	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/14/1981	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
04/19/1979	SUPPL-13	Labeling		Label is not available on this site.
05/05/1977	SUPPL-11	Labeling		Label is not available on this site.
01/15/1975	SUPPL-9	Labeling		Label is not available on this site.
07/01/1974	SUPPL-6	Unspecified		Label is not available on this site.

Labels for NDA 012015

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2013	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf
04/22/2013	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf

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