Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040251
Company: MIKART

Products on ANDA 040251

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040251

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40251_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40251ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040251_trihexyphenidyl_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/13/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 040251

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40251_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040251

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