Details for New Drug Application (NDA): 216338
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NDA 216338 describes PACLITAXEL, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Norvium Bioscience, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Am Regent, Hengrui Pharma, and Teva Pharms Inc, and is included in nineteen NDAs. It is available from sixteen suppliers. Additional details are available on the PACLITAXEL profile page.
The generic ingredient in PACLITAXEL is paclitaxel. There are sixty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
The generic ingredient in PACLITAXEL is paclitaxel. There are sixty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Summary for 216338
| Tradename: | PACLITAXEL |
| Applicant: | Teva Pharms Inc |
| Ingredient: | paclitaxel |
| Patents: | 0 |
Pharmacology for NDA: 216338
| Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for 216338
Suppliers and Packaging for NDA: 216338
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PACLITAXEL | paclitaxel | POWDER;INTRAVENOUS | 216338 | NDA | Teva Pharmaceuticals, Inc. | 0480-3290 | 0480-3290-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-3290-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | May 11, 2023 | TE: | AB | RLD: | Yes | ||||
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