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Details for New Drug Application (NDA): 203877

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NDA 203877 describes DOCETAXEL, which is a drug marketed by Apotex Inc, Sandoz, Hospira Inc, Eagle Pharms, Actavis Inc, Pfizer Labs, Teva Pharms Usa, Dr Reddys Labs Ltd, and Accord Hlthcare, and is included in nine NDAs. It is available from eleven suppliers. There are two patents protecting this drug. Additional details are available on the DOCETAXEL profile page.

The generic ingredient in DOCETAXEL is docetaxel. There are thirty-nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for NDA: 203877

Tradename:
DOCETAXEL
Applicant:
Teva Pharms Usa
Ingredient:
docetaxel
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203877

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 203877

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL
docetaxel
INJECTABLE;INJECTION 203877 ANDA Teva Parenteral Medicines, Inc. 0703-5720 0703-5720-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-5720-01) > 1 mL in 1 VIAL, SINGLE-USE
DOCETAXEL
docetaxel
INJECTABLE;INJECTION 203877 ANDA Teva Parenteral Medicines, Inc. 0703-5730 0703-5730-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-5730-01) > 4 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Sep 16, 2015TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/4ML (20MG/ML)
Approval Date:Sep 16, 2015TE:APRLD:No


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