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Serving 500+ biopharmaceutical companies globally:

Healthtrust
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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207326

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NDA 207326 describes PACITAXEL, which is a drug marketed by Gland Pharma Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the PACITAXEL profile page.

The generic ingredient in PACITAXEL is paclitaxel. There are sixty-seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for NDA: 207326

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 207326

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 207326

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACITAXEL
paclitaxel
INJECTABLE;INJECTION 207326 ANDA Breckenridge Pharmaceutical, Inc. 51991-936 51991-936-98 1 VIAL, MULTI-DOSE in 1 CARTON (51991-936-98) > 5 mL in 1 VIAL, MULTI-DOSE
PACITAXEL
paclitaxel
INJECTABLE;INJECTION 207326 ANDA Breckenridge Pharmaceutical, Inc. 51991-937 51991-937-98 1 VIAL, MULTI-DOSE in 1 CARTON (51991-937-98) > 16.7 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Aug 23, 2016TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Argus Health
Medtronic
UBS
US Department of Justice
Harvard Business School
Teva
Cerilliant
Fuji
Boehringer Ingelheim
Mallinckrodt

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