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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090561

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NDA 090561 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 090561

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

Pharmacology for NDA: 090561

Medical Subject Heading (MeSH) Categories for 090561

Suppliers and Packaging for NDA: 090561

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIDOVUDINE zidovudine TABLET;ORAL 090561 ANDA Cipla Ltd. 53104-0101 53104-0101-2 60 TABLET, FILM COATED in 1 BOTTLE (53104-0101-2)
ZIDOVUDINE zidovudine TABLET;ORAL 090561 ANDA Cipla Ltd. 53104-0101 53104-0101-9 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (53104-0101-9)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 27, 2010TE:ABRLD:No


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