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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064140

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NDA 064140 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 064140

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

Pharmacology for NDA: 064140

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 064140

Suppliers and Packaging for NDA: 064140

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 064140 ANDA Teva Parenteral Medicines, Inc. 0703-5040 0703-5040-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-5040-01) > 100 mL in 1 VIAL, MULTI-DOSE
DOXORUBICIN HYDROCHLORIDE doxorubicin hydrochloride INJECTABLE;INJECTION 064140 ANDA Teva Parenteral Medicines, Inc. 0703-5043 0703-5043-03 10 VIAL, SINGLE-DOSE in 1 TRAY (0703-5043-03) > 5 mL in 1 VIAL, SINGLE-DOSE (0703-5043-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Jul 28, 1995TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:Jul 28, 1995TE:APRLD:No


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