Details for New Drug Application (NDA): 217713
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NDA 217713 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 217713
| Tradename: | PAZOPANIB HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | pazopanib hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217713
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 217713 | ANDA | Golden State Medical Supply, Inc. | 51407-872 | 51407-872-12 | 120 TABLET in 1 BOTTLE (51407-872-12) |
| PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 217713 | ANDA | Apotex Corp. | 60505-4779 | 60505-4779-5 | 500 TABLET in 1 BOTTLE (60505-4779-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Oct 19, 2023 | TE: | AB | RLD: | No | ||||
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