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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078922

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NDA 078922 describes ZIDOVUDINE, which is a drug marketed by Mylan Pharms Inc, Ranbaxy Labs Ltd, Aurobindo Pharma Ltd, Matrix Labs Ltd, Liaoning Chengda, West-ward Pharms Int, Cipla Ltd, Luitpold, Hec Pharm Usa Inc, Cipla, Aurobindo, Hetero Labs Ltd Iii, and Aurobindo Pharma, 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 NDA: 078922

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

Pharmacology for NDA: 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 0378-6106-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6106-91)
ZIDOVUDINE
zidovudine
TABLET;ORAL 078922 ANDA State of Florida DOH Central Pharmacy 53808-0878 53808-0878-2 60 TABLET, FILM COATED in 1 BLISTER PACK (53808-0878-2)

Summary for product number 001

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


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Cerilliant

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