Drugs@FDA: FDA Approved Drug Products

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

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

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