Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012003
Company: ABBVIE

Products on NDA 012003

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AKINETON	BIPERIDEN HYDROCHLORIDE	2MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012003

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/1959	ORIG-1	Approval	Type 1 - New Molecular Entity	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
05/09/2002	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
02/04/2002	SUPPL-24	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12003s24ltr.pdf
10/25/2000	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
12/17/1987	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/23/2001	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf
07/23/2001	SUPPL-20	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf
07/23/2001	SUPPL-19	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf
07/23/2001	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12003s18s19s20s21ltr.pdf
01/30/1980	SUPPL-16	Labeling		Label is not available on this site.
06/29/1976	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/14/1976	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
09/24/1975	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/12/1975	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/1975	SUPPL-10	Labeling		Label is not available on this site.