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Generated: September 23, 2018

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Details for New Drug Application (NDA): 202058

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NDA 202058 describes ZIDOVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Liaoning Chengda, Luitpold, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, 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 thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the zidovudine profile page.
Summary for 202058
Tradename:ZIDOVUDINE
Applicant:Hec Pharm
Ingredient:zidovudine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202058
Medical Subject Heading (MeSH) Categories for 202058
Suppliers and Packaging for NDA: 202058
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIDOVUDINE zidovudine TABLET;ORAL 202058 ANDA Lannett Company, Inc. 0527-1905 0527-1905-06 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1905-06)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Oct 7, 2011TE:RLD:No

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