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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Colorcon
Cerilliant
Baxter
Covington
Citi
Express Scripts
Novartis
Chinese Patent Office
Merck
Moodys

Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078349

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NDA 078349 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 078349

Tradename:
1
Applicant:
1
Ingredient:
1
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 Edenbridge Pharmaceuticals, LLC 42799-403 42799-403-01 100 CAPSULE in 1 BOTTLE (42799-403-01)
ZIDOVUDINE
zidovudine
CAPSULE;ORAL 078349 ANDA Cipla Ltd. 53104-0100 53104-0100-4 100 CAPSULE in 1 BOTTLE (53104-0100-4)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Queensland Health
Express Scripts
UBS
McKinsey
US Department of Justice
Chubb
Julphar
Daiichi Sankyo
Cipla
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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