Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071654
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG 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
02/18/1988 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-13 Labeling-Package Insert

Label is not available on this site.

12/01/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/06/1996 SUPPL-11 Labeling

Label is not available on this site.

09/26/1995 SUPPL-10 Labeling

Label is not available on this site.

12/23/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/01/1993 SUPPL-7 Labeling

Label is not available on this site.

04/03/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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