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Details for New Drug Application (NDA): 091630

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NDA 091630 describes TRIHEXYPHENIDYL HYDROCHLORIDE, which is a drug marketed by Watson Labs, Pharm Ventures, Nylos, Natco Pharma Ltd, Vangard, Hikma Pharms Llc, Mikart, Vintage Pharms, and Pharm Assoc, and is included in thirteen NDAs. It is available from nineteen suppliers. Additional details are available on the TRIHEXYPHENIDYL HYDROCHLORIDE profile page.

The generic ingredient in TRIHEXYPHENIDYL HYDROCHLORIDE is trihexyphenidyl hydrochloride. There are three drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the trihexyphenidyl hydrochloride profile page.

Summary for NDA: 091630

Tradename:
TRIHEXYPHENIDYL HYDROCHLORIDE
Applicant:
Natco Pharma Ltd
Ingredient:
trihexyphenidyl hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 091630

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIHEXYPHENIDYL HYDROCHLORIDE
trihexyphenidyl hydrochloride
TABLET;ORAL 091630 ANDA Rising Pharmaceuticals, Inc. 16571-160 16571-160-10 100 TABLET in 1 BOTTLE (16571-160-10)
TRIHEXYPHENIDYL HYDROCHLORIDE
trihexyphenidyl hydrochloride
TABLET;ORAL 091630 ANDA Rising Pharmaceuticals, Inc. 16571-160 16571-160-11 1000 TABLET in 1 BOTTLE (16571-160-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 17, 2010TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 17, 2010TE:AARLD:No


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