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Generated: December 18, 2018

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Details for New Drug Application (NDA): 075184

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NDA 075184 describes PACLITAXEL, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Fresenius Kabi Usa, Hospira, Mylan, Mylan Labs Ltd, Pliva Lachema, Sandoz Inc, Teva Pharms, Teva Pharms Usa, and West-ward Pharms Int, and is included in thirteen NDAs. It is available from six 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. Twelve suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Summary for 075184
Tradename:PACLITAXEL
Applicant:Teva Pharms
Ingredient:paclitaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075184
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 075184
Suppliers and Packaging for NDA: 075184
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACLITAXEL paclitaxel INJECTABLE;INJECTION 075184 ANDA Teva Parenteral Medicines, Inc. 0703-4764 0703-4764-81 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4764-81) > 5 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL paclitaxel INJECTABLE;INJECTION 075184 ANDA Teva Parenteral Medicines, Inc. 0703-4764 0703-4764-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4764-01) > 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Jan 25, 2002TE:APRLD:No

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