Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085031
Company: ANI PHARMS

Products on ANDA 085031

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085031

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/1976	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-287	Labeling-Package Insert		Label is not available on this site.
11/17/2014	SUPPL-286	Labeling-Package Insert		Label is not available on this site.
06/18/1997	SUPPL-285	Manufacturing (CMC)		Label is not available on this site.
06/11/1995	SUPPL-284	Labeling		Label is not available on this site.
02/15/1995	SUPPL-283	Manufacturing (CMC)		Label is not available on this site.
02/16/1995	SUPPL-282	Manufacturing (CMC)		Label is not available on this site.
11/30/1994	SUPPL-281	Manufacturing (CMC)		Label is not available on this site.
09/06/1994	SUPPL-280	Manufacturing (CMC)		Label is not available on this site.
06/17/1994	SUPPL-279	Manufacturing (CMC)		Label is not available on this site.
03/23/1994	SUPPL-278	Manufacturing (CMC)		Label is not available on this site.
08/18/1993	SUPPL-277	Labeling		Label is not available on this site.
06/12/1992	SUPPL-276	Labeling		Label is not available on this site.
12/31/1991	SUPPL-273	Labeling		Label is not available on this site.
06/10/1992	SUPPL-272	Manufacturing (CMC)		Label is not available on this site.
04/05/1989	SUPPL-271	Manufacturing (CMC)		Label is not available on this site.
03/31/1988	SUPPL-269	Manufacturing (CMC)		Label is not available on this site.
03/31/1988	SUPPL-268	Manufacturing (CMC)		Label is not available on this site.
09/30/1987	SUPPL-266	Manufacturing (CMC)		Label is not available on this site.
11/04/1987	SUPPL-265	Manufacturing (CMC)		Label is not available on this site.
09/30/1987	SUPPL-263	Manufacturing (CMC)		Label is not available on this site.
04/28/1986	SUPPL-262	Manufacturing (CMC)		Label is not available on this site.
04/28/1986	SUPPL-261	Manufacturing (CMC)		Label is not available on this site.
03/12/1986	SUPPL-260	Manufacturing (CMC)		Label is not available on this site.
03/12/1986	SUPPL-259	Manufacturing (CMC)		Label is not available on this site.
12/19/1985	SUPPL-257	Manufacturing (CMC)		Label is not available on this site.
12/06/1985	SUPPL-256	Manufacturing (CMC)		Label is not available on this site.
12/06/1985	SUPPL-255	Manufacturing (CMC)		Label is not available on this site.
09/11/1985	SUPPL-254	Manufacturing (CMC)		Label is not available on this site.
12/21/1984	SUPPL-252	Manufacturing (CMC)		Label is not available on this site.
12/06/1985	SUPPL-251	Manufacturing (CMC)		Label is not available on this site.
07/27/1984	SUPPL-250	Manufacturing (CMC)		Label is not available on this site.
03/15/1984	SUPPL-249	Manufacturing (CMC)		Label is not available on this site.
12/16/1983	SUPPL-248	Manufacturing (CMC)		Label is not available on this site.
06/18/1982	SUPPL-244	Manufacturing (CMC)		Label is not available on this site.
12/12/1983	SUPPL-239	Manufacturing (CMC)		Label is not available on this site.