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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050629

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NDA 050629 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: 050629

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

Pharmacology for NDA: 050629

Ingredient-typeAnthracyclines
Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 050629

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride
INJECTABLE;INJECTION 050629 NDA Pfizer Laboratories Div Pfizer Inc 0069-3030 0069-3030-20 1 VIAL, SINGLE-DOSE in 1 CARTON (0069-3030-20) > 5 mL in 1 VIAL, SINGLE-DOSE
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride
INJECTABLE;INJECTION 050629 NDA Pfizer Laboratories Div Pfizer Inc 0069-3031 0069-3031-20 1 VIAL, SINGLE-DOSE in 1 CARTON (0069-3031-20) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Dec 23, 1987TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:May 3, 1988TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150MG/75ML
Approval Date:Mar 28, 2011TE:RLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Teva
Queensland Health
Cantor Fitzgerald
Moodys
Dow
Cipla
Fish and Richardson
Cerilliant
Colorcon
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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