Details for New Drug Application (NDA): 040251
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NDA 040251 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 040251
| Tradename: | TRIHEXYPHENIDYL HYDROCHLORIDE |
| Applicant: | Mikart |
| Ingredient: | trihexyphenidyl hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 040251
Suppliers and Packaging for NDA: 040251
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIHEXYPHENIDYL HYDROCHLORIDE | trihexyphenidyl hydrochloride | ELIXIR;ORAL | 040251 | ANDA | Akorn | 61748-054 | 61748-054-16 | 473 mL in 1 BOTTLE, PLASTIC (61748-054-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | ELIXIR;ORAL | Strength | 2MG/5ML | ||||
| Approval Date: | Sep 27, 1999 | TE: | AA | RLD: | No | ||||
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