Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084364
Company: WATSON LABS

Products on ANDA 084364

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084364

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/1974	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
06/19/2007	SUPPL-54	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
12/06/2001	SUPPL-53	Manufacturing (CMC)-Facility		Label is not available on this site.
04/25/2001	SUPPL-52	Manufacturing (CMC)-Control		Label is not available on this site.
09/02/1997	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.
10/08/1997	SUPPL-49	Manufacturing (CMC)		Label is not available on this site.
09/02/1997	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
09/02/1997	SUPPL-47	Manufacturing (CMC)		Label is not available on this site.
12/11/1997	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
01/28/1991	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
11/14/1988	SUPPL-38	Labeling		Label is not available on this site.
05/28/1985	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
05/28/1985	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
01/22/1985	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
02/09/1984	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
01/18/1983	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 084364

TRIHEXYPHENIDYL HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	091630	NATCO PHARMA LTD
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	040254	NOVITIUM PHARMA
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	084364	WATSON LABS