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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090094

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NDA 090094 describes DIDANOSINE, which is a drug marketed by Aurobindo Pharma, Barr, Mylan Pharms Inc, and Aurobindo, and is included in five NDAs. It is available from four suppliers. Additional details are available on the DIDANOSINE profile page.

The generic ingredient in DIDANOSINE is didanosine. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the didanosine profile page.

Summary for 090094

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

Pharmacology for NDA: 090094

Medical Subject Heading (MeSH) Categories for 090094

Suppliers and Packaging for NDA: 090094

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIDANOSINE didanosine CAPSULE, DELAYED REL PELLETS;ORAL 090094 ANDA Aurobindo Pharma Limited 65862-310 65862-310-14 10 BLISTER PACK in 1 CARTON (65862-310-14) > 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
DIDANOSINE didanosine CAPSULE, DELAYED REL PELLETS;ORAL 090094 ANDA Aurobindo Pharma Limited 65862-310 65862-310-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-310-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength125MG
Approval Date:Sep 24, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength200MG
Approval Date:Sep 24, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength250MG
Approval Date:Sep 24, 2008TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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Novartis
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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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