Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088886
Company: PLIVA

Products on ANDA 088886

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088886

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/1984	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
06/25/2001	SUPPL-19	Labeling		Label is not available on this site.
10/05/2000	SUPPL-17	Labeling		Label is not available on this site.
07/07/2000	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
05/24/1995	SUPPL-15	Labeling		Label is not available on this site.
07/14/1995	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/14/1995	SUPPL-13	Labeling		Label is not available on this site.
05/11/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/04/1993	SUPPL-11	Labeling		Label is not available on this site.
05/26/1992	SUPPL-10	Labeling		Label is not available on this site.
10/26/1990	SUPPL-8	Labeling		Label is not available on this site.
02/14/1990	SUPPL-7	Bioequivalence		Label is not available on this site.
07/29/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/22/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/17/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/17/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/17/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.