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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203622

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NDA 203622 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Mylan Labs Ltd, Alvogen Inc, Sun Pharm Inds, West-ward Pharms Int, Actavis Inc, Gland Pharma Ltd, 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 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 203622

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

Pharmacology for NDA: 203622

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 203622

Suppliers and Packaging for NDA: 203622

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride
INJECTABLE;INJECTION 203622 ANDA Actavis Pharma, Inc. 45963-733 45963-733-55 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-55) > 5 mL in 1 VIAL, SINGLE-DOSE
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride
INJECTABLE;INJECTION 203622 ANDA Actavis Pharma, Inc. 45963-733 45963-733-57 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-57) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Jun 27, 2014TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:Jun 27, 2014TE:APRLD:No


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