Details for New Drug Application (NDA): 084364
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NDA 084364 describes TRIHEXYPHENIDYL HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Pharm Assoc, Pharm Ventures, Hikma, Natco Pharma Ltd, Novitium Pharma, Nylos, Vangard, and Watson Labs, and is included in thirteen NDAs. It is available from eight 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. Eight suppliers are listed for this compound. 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. Eight suppliers are listed for this compound. Additional details are available on the trihexyphenidyl hydrochloride profile page.
Summary for 084364
| Tradename: | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Applicant: | Watson Labs |
| Ingredient: | trihexyphenidyl hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 084364
Suppliers and Packaging for NDA: 084364
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIHEXYPHENIDYL HYDROCHLORIDE | trihexyphenidyl hydrochloride | TABLET;ORAL | 084364 | ANDA | Actavis Pharma, Inc. | 0591-5337 | 0591-5337-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5337-01) |
| TRIHEXYPHENIDYL HYDROCHLORIDE | trihexyphenidyl hydrochloride | TABLET;ORAL | 084364 | ANDA | Actavis Pharma, Inc. | 0591-5337 | 0591-5337-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5337-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | No | ||||
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