Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071609
Company: TEVA PHARMS
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 Yes
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-28 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071609s028lbl.pdf
10/29/2007 SUPPL-25 Labeling

Label is not available on this site.

07/09/2007 SUPPL-24 Labeling

Label is not available on this site.

05/23/2006 SUPPL-23 Labeling

Label is not available on this site.

07/08/2005 SUPPL-22 Labeling

Label is not available on this site.

03/13/2002 SUPPL-18 Labeling

Label is not available on this site.

02/27/2002 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

02/27/2002 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/31/2001 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2002 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

06/17/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/13/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/12/1993 SUPPL-5 Labeling

Label is not available on this site.

05/27/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/29/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/29/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/07/1990 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/17/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071609s028lbl.pdf

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

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