Details for New Drug Application (NDA): 091630
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NDA 091630 describes TRIHEXYPHENIDYL HYDROCHLORIDE, which is a drug marketed by Mikart, 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 nine 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the trihexyphenidyl hydrochloride profile page.
Summary for 091630
| Tradename: | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Applicant: | Natco Pharma Ltd |
| Ingredient: | trihexyphenidyl hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 091630
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 | Natco Pharma Limited | 63850-0021 | 63850-0021-1 | 100 TABLET in 1 BOTTLE (63850-0021-1) |
| TRIHEXYPHENIDYL HYDROCHLORIDE | trihexyphenidyl hydrochloride | TABLET;ORAL | 091630 | ANDA | Natco Pharma Limited | 63850-0021 | 63850-0021-2 | 250 TABLET in 1 BOTTLE (63850-0021-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Nov 17, 2010 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 17, 2010 | TE: | AA | RLD: | No | ||||
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