Details for New Drug Application (NDA): 218231
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NDA 218231 describes PAZOPANIB HYDROCHLORIDE, which is a drug marketed by Apotex, Novugen, Sun Pharm, and Teva Pharms Inc, and is included in four NDAs. It is available from six suppliers. Additional details are available on the PAZOPANIB HYDROCHLORIDE profile page.
The generic ingredient in PAZOPANIB HYDROCHLORIDE is pazopanib hydrochloride. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pazopanib hydrochloride profile page.
The generic ingredient in PAZOPANIB HYDROCHLORIDE is pazopanib hydrochloride. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pazopanib hydrochloride profile page.
Summary for 218231
| Tradename: | PAZOPANIB HYDROCHLORIDE |
| Applicant: | Novugen |
| Ingredient: | pazopanib hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218231
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 218231 | ANDA | Novugen Pharma (USA) LLC. | 82293-022 | 82293-022-10 | 120 TABLET, FILM COATED in 1 BOTTLE (82293-022-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Apr 23, 2024 | TE: | AB | RLD: | No | ||||
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