Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071422
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription AB No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription AB No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription AB No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription AB No No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription AB 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
11/09/1987 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-30 Labeling-Package Insert

Label is not available on this site.

12/12/2007 SUPPL-28 Labeling

Label is not available on this site.

06/25/2007 SUPPL-27 Labeling

Label is not available on this site.

01/30/2006 SUPPL-24 Labeling

Label is not available on this site.

09/30/2005 SUPPL-21 Labeling

Label is not available on this site.

08/03/2005 SUPPL-20 Labeling

Label is not available on this site.

07/07/2005 SUPPL-19 Labeling

Label is not available on this site.

10/31/2000 SUPPL-18 Labeling

Label is not available on this site.

11/26/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/21/1995 SUPPL-15 Labeling

Label is not available on this site.

08/25/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/08/1993 SUPPL-13 Labeling

Label is not available on this site.

08/09/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/28/1989 SUPPL-11 Labeling

Label is not available on this site.

04/03/1989 SUPPL-10 Labeling

Label is not available on this site.

03/15/1989 SUPPL-9 Labeling

Label is not available on this site.

05/12/1988 SUPPL-7 Labeling

Label is not available on this site.

04/19/1988 SUPPL-6 Labeling

Label is not available on this site.

03/30/1988 SUPPL-5 Labeling

Label is not available on this site.

03/30/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 212624 AJANTA PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 207482 AMNEAL PHARMS CO
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 211603 AUROBINDO PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 212624 AJANTA PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 207482 AMNEAL PHARMS CO
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 211603 AUROBINDO PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 212624 AJANTA PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 207482 AMNEAL PHARMS CO
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 211603 AUROBINDO PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 071437 PAR PHARM

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 212624 AJANTA PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 207482 AMNEAL PHARMS CO
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 211603 AUROBINDO PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 212624 AJANTA PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 207482 AMNEAL PHARMS CO
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 211603 AUROBINDO PHARMA LTD
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English