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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078349

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NDA 078349 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 fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the zidovudine profile page.
Summary for 078349
Tradename:ZIDOVUDINE
Applicant:Cipla Ltd
Ingredient:zidovudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 078349
Medical Subject Heading (MeSH) Categories for 078349
Suppliers and Packaging for NDA: 078349
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIDOVUDINE zidovudine CAPSULE;ORAL 078349 ANDA Cipla Ltd. 53104-0100 N 53104-0100-4
ZIDOVUDINE zidovudine CAPSULE;ORAL 078349 ANDA Cipla Ltd. 53104-0100 N 53104-0100-6

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 23, 2007TE:ABRLD:No

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