Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080713
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIPELENNAMINE HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE 50MG 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
01/18/1973 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/14/1999 SUPPL-36 Labeling

Label is not available on this site.

10/15/1990 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/21/1989 SUPPL-31 Labeling

Label is not available on this site.

10/15/1990 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/15/1990 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/08/1986 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/08/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/28/1983 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/28/1982 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/28/1982 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

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