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Serving 500+ biopharmaceutical companies globally:

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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091418

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NDA 091418 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Mylan Labs Ltd, Alvogen Inc, Sun Pharm Inds, West-ward Pharms Int, Actavis Inc, Pharmacia And Upjohn, Pharmachemie Bv, Teva Pharms Usa, Sandoz Inc, Fresenius Kabi Usa, Amneal Pharms Co, Sagent Pharms, Dr Reddys Labs Ltd, and Sun Pharma Global, and is included in nineteen NDAs. It is available from eleven 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. Fourteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

Summary for NDA: 091418

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

Pharmacology for NDA: 091418

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 091418

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride
INJECTABLE;INJECTION 091418 ANDA Sun Pharmaceutical Industries Limited 62756-826 62756-826-40 1 VIAL, SINGLE-DOSE in 1 BOX (62756-826-40) > 25 mL in 1 VIAL, SINGLE-DOSE
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride
INJECTABLE;INJECTION 091418 ANDA Sun Pharmaceutical Industries Limited 62756-827 62756-827-40 1 VIAL, MULTI-DOSE in 1 BOX (62756-827-40) > 100 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Feb 15, 2012TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Army
US Department of Justice
Farmers Insurance
Healthtrust
Argus Health
Johnson and Johnson
Harvard Business School
Express Scripts
Baxter
Teva

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