Details for New Drug Application (NDA): 219034
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NDA 219034 describes PAZOPANIB HYDROCHLORIDE, which is a drug marketed by Apotex, Eugia Pharma, Novugen, Sun Pharm, and Teva Pharms Inc, and is included in five NDAs. It is available from seven 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the pazopanib hydrochloride profile page.
Summary for 219034
| Tradename: | PAZOPANIB HYDROCHLORIDE |
| Applicant: | Eugia Pharma |
| Ingredient: | pazopanib hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219034
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 219034 | ANDA | Aurobindo Pharma Limited | 59651-582 | 59651-582-08 | 120 TABLET, FILM COATED in 1 BOTTLE (59651-582-08) |
| PAZOPANIB HYDROCHLORIDE | pazopanib hydrochloride | TABLET;ORAL | 219034 | ANDA | Aurobindo Pharma Limited | 59651-582 | 59651-582-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-582-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Dec 4, 2024 | TE: | AB | RLD: | No | ||||
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