Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085083
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE 50MG CAPSULE;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
06/29/1976 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
07/17/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/23/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/02/1991 SUPPL-33 Labeling

Label is not available on this site.

08/31/1990 SUPPL-32 Labeling

Label is not available on this site.

12/21/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/21/1988 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/21/1988 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/14/1986 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/03/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/03/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/03/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/16/1983 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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