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Details for New Drug Application (NDA): 203551

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NDA 203551 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: 203551

Tradename:
DOCETAXEL
Applicant:
Actavis Inc
Ingredient:
docetaxel
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203551

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 203551

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL
docetaxel
INJECTABLE;INJECTION 203551 ANDA Sagent Pharmaceuticals 25021-222 25021-222-01 1 VIAL in 1 CARTON (25021-222-01) > 1 mL in 1 VIAL
DOCETAXEL
docetaxel
INJECTABLE;INJECTION 203551 ANDA Sagent Pharmaceuticals 25021-222 25021-222-04 1 VIAL in 1 CARTON (25021-222-04) > 4 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Apr 12, 2013TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/4ML (20MG/ML)
Approval Date:Apr 12, 2013TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength140MG/7ML (20MG/ML)
Approval Date:Apr 12, 2013TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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