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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040254
Company: NOVITIUM PHARMA

Products on ANDA 040254

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	AA	No	No
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040254

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40254_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40254ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040254_trihexyphenidyl_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2000	SUPPL-2	Labeling		Label is not available on this site.
09/29/2000	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for ANDA 040254

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/24/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40254_Trihexyphenidyl%20Hydrochloride_Prntlbl.pdf

Therapeutic Equivalents for ANDA 040254

TRIHEXYPHENIDYL HYDROCHLORIDE

TABLET;ORAL; 2MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AA	091630	NATCO PHARMA LTD
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AA	040254	NOVITIUM PHARMA
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AA	084363	WATSON LABS

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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