Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071918
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE;ORAL Prescription AA 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
07/20/1988 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-14 Labeling-Package Insert

Label is not available on this site.

08/13/2008 SUPPL-12 Labeling

Label is not available on this site.

06/26/2007 SUPPL-10 Labeling

Label is not available on this site.

11/05/2001 SUPPL-8 Labeling

Label is not available on this site.

01/11/2001 SUPPL-7 Labeling

Label is not available on this site.

08/17/1995 SUPPL-6 Labeling

Label is not available on this site.

08/17/1995 SUPPL-5 Labeling

Label is not available on this site.

11/24/1993 SUPPL-4 Labeling

Label is not available on this site.

02/12/1992 SUPPL-3 Labeling

Label is not available on this site.

04/02/1991 SUPPL-2 Labeling

Label is not available on this site.

DOXEPIN HYDROCHLORIDE

CONCENTRATE;ORAL; EQ 10MG BASE/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE;ORAL Prescription No AA 074721 LANNETT CO INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE;ORAL Prescription No AA 071609 TEVA PHARMS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML CONCENTRATE;ORAL Prescription No AA 071918 WOCKHARDT BIO AG

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