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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Argus Health
Cerilliant
Cantor Fitzgerald
Healthtrust
Merck
McKinsey
Chubb
Harvard Business School

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078922

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NDA 078922 describes ZIDOVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Liaoning Chengda, Luitpold, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm Usa Inc, Hetero Labs Ltd Iii, Matrix Labs Ltd, Mylan Pharms Inc, Ranbaxy Labs Ltd, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from fifteen suppliers. Additional details are available on the ZIDOVUDINE profile page.

The generic ingredient in ZIDOVUDINE is zidovudine. There are twenty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the zidovudine profile page.
Summary for 078922
Tradename:ZIDOVUDINE
Applicant:Mylan Pharms Inc
Ingredient:zidovudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 078922
Medical Subject Heading (MeSH) Categories for 078922
Suppliers and Packaging for NDA: 078922
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIDOVUDINE zidovudine TABLET;ORAL 078922 ANDA Mylan Pharmaceuticals Inc. 0378-6106 N 0378-6106-91
ZIDOVUDINE zidovudine TABLET;ORAL 078922 ANDA State of Florida DOH Central Pharmacy 53808-0878 E 53808-0878-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Feb 14, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Cerilliant
McKesson
Johnson and Johnson
UBS
Mallinckrodt
Healthtrust
McKinsey
Dow

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