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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200901

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NDA 200901 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Inc, Alvogen Inc, Amneal Pharms Co, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Pharmachemie Bv, Pharmacia And Upjohn, Sagent Pharms, Sandoz Inc, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Dr Reddys Labs Ltd, and Sun Pharma Global, and is included in twenty NDAs. It is available from twelve suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for 200901

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 200901

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 200901

Suppliers and Packaging for NDA: 200901

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 200901 ANDA Amneal-Agila, LLC 53150-314 53150-314-10 10 VIAL, SINGLE-DOSE in 1 CARTON (53150-314-10) > 10 mL in 1 VIAL, SINGLE-DOSE (53150-314-01)
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 200901 ANDA Amneal-Agila, LLC 53150-315 53150-315-01 1 VIAL, SINGLE-DOSE in 1 CARTON (53150-315-01) > 25 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Feb 14, 2012TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Dow
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