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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078957

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NDA 078957 describes STAVUDINE, which is a drug marketed by Aurobindo Pharma, Hetero Labs Ltd Iii, Mylan, Mylan Labs Ltd, and Cipla Ltd, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the STAVUDINE profile page.

The generic ingredient in STAVUDINE is stavudine. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the stavudine profile page.

Summary for 078957

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

Pharmacology for NDA: 078957

Medical Subject Heading (MeSH) Categories for 078957

Suppliers and Packaging for NDA: 078957

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STAVUDINE stavudine CAPSULE;ORAL 078957 ANDA KAISER FOUNDATION HOSPITALS 0179-0028 0179-0028-70 30 CAPSULE in 1 BOX, UNIT-DOSE (0179-0028-70)
STAVUDINE stavudine CAPSULE;ORAL 078957 ANDA Camber Pharmaceuticals, Inc. 31722-515 31722-515-01 100 CAPSULE in 1 BOTTLE (31722-515-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Dec 29, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Dec 29, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Dec 29, 2008TE:ABRLD:No


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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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