Details for New Drug Application (NDA): 211875
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NDA 211875 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 211875
| Tradename: | PACLITAXEL |
| Applicant: | Am Regent |
| Ingredient: | paclitaxel |
| Patents: | 0 |
Pharmacology for NDA: 211875
| Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for 211875
Suppliers and Packaging for NDA: 211875
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PACLITAXEL | paclitaxel | POWDER;INTRAVENOUS | 211875 | NDA | American Regent, Inc. | 0517-4300 | 0517-4300-01 | 1 VIAL in 1 CARTON (0517-4300-01) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Jul 27, 2022 | TE: | AB | RLD: | Yes | ||||
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