Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040218
Company: VINTAGE PHARMS

Products on ANDA 040218

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET;ORAL	Discontinued	None	No	No
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	No	No
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET;ORAL	Discontinued	None	No	No
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET;ORAL	Discontinued	None	No	No
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040218

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/1997	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
04/25/2016	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
07/17/2014	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
04/26/2010	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/21/2007	SUPPL-14	Labeling		Label is not available on this site.
06/29/2007	SUPPL-12	Labeling		Label is not available on this site.
10/06/2005	SUPPL-9	Labeling		Label is not available on this site.
08/03/2005	SUPPL-8	Labeling		Label is not available on this site.
03/26/2002	SUPPL-3	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.