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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077981

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NDA 077981 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 077981

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

Pharmacology for NDA: 077981

Medical Subject Heading (MeSH) Categories for 077981

Suppliers and Packaging for NDA: 077981

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIDOVUDINE zidovudine SYRUP;ORAL 077981 ANDA Edenbridge Pharmaceuticals, LLC 42799-404 42799-404-01 240 mL in 1 BOTTLE (42799-404-01)
ZIDOVUDINE zidovudine SYRUP;ORAL 077981 ANDA Cipla Ltd. 53104-0105 53104-0105-9 240 mL in 1 BOTTLE (53104-0105-9)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Jun 26, 2008TE:AARLD:No


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