Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012003
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKINETON BIPERIDEN HYDROCHLORIDE 2MG TABLET;ORAL Discontinued None No No
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.

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