Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070792
Company: MYLAN

Products on ANDA 070792

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE; ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070792

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/1986	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
10/25/2000	SUPPL-13	Labeling		Label is not available on this site.
02/25/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/05/1995	SUPPL-10	Labeling		Label is not available on this site.
11/19/1993	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/30/1993	SUPPL-8	Labeling		Label is not available on this site.
06/22/1989	SUPPL-6	Labeling		Label is not available on this site.
07/11/1989	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/28/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070792

DOXEPIN HYDROCHLORIDE

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	070792	MYLAN