Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040177
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG/5ML ELIXIR;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
04/17/1997 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
06/30/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/04/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

TRIHEXYPHENIDYL HYDROCHLORIDE

ELIXIR;ORAL; 2MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG/5ML ELIXIR;ORAL Prescription No AA 040251 MIKART
TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG/5ML ELIXIR;ORAL Prescription No AA 040177 PHARM ASSOC

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