Details for New Drug Application (NDA): 040254
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NDA 040254 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 040254
| Tradename: | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | trihexyphenidyl hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 040254
Suppliers and Packaging for NDA: 040254
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIHEXYPHENIDYL HYDROCHLORIDE | trihexyphenidyl hydrochloride | TABLET;ORAL | 040254 | ANDA | Golden State Medical Supply Inc. | 51407-265 | 51407-265-01 | 100 TABLET in 1 BOTTLE (51407-265-01) |
| TRIHEXYPHENIDYL HYDROCHLORIDE | trihexyphenidyl hydrochloride | TABLET;ORAL | 040254 | ANDA | Golden State Medical Supply Inc. | 51407-266 | 51407-266-01 | 100 TABLET in 1 BOTTLE (51407-266-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Dec 24, 1998 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 24, 1998 | TE: | AA | RLD: | No | ||||
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