Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070828
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE 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
05/15/1986 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
07/17/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/09/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1995 SUPPL-6 Labeling

Label is not available on this site.

03/01/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/19/1993 SUPPL-4 Labeling

Label is not available on this site.

05/01/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/17/1989 SUPPL-2 Labeling

Label is not available on this site.

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