Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074721
Company: LANNETT CO INC

Products on ANDA 074721

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074721

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74721ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/14/2008	SUPPL-9	Labeling		Label is not available on this site.
06/26/2007	SUPPL-8	Labeling		Label is not available on this site.
06/05/2006	SUPPL-7	Labeling		Label is not available on this site.
08/15/2005	SUPPL-6	Labeling		Label is not available on this site.
04/30/2002	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/30/2000	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074721

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