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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 216874


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NDA 216874 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.
Summary for 216874
Tradename:PACLITAXEL
Applicant:Alembic
Ingredient:paclitaxel
Patents:0
Pharmacology for NDA: 216874
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 216874
Suppliers and Packaging for NDA: 216874
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACLITAXEL paclitaxel INJECTABLE;INJECTION 216874 ANDA Alembic Pharmaceuticals Limited 46708-620 46708-620-05 1 VIAL, MULTI-DOSE in 1 CARTON (46708-620-05) / 5 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL paclitaxel INJECTABLE;INJECTION 216874 ANDA Alembic Pharmaceuticals Limited 46708-621 46708-621-17 1 VIAL, MULTI-DOSE in 1 CARTON (46708-621-17) / 16.7 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Oct 20, 2022TE:APRLD:No

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