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Generated: August 17, 2017

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Details for New Drug Application (NDA): 090094

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NDA 090094 describes DIDANOSINE, which is a drug marketed by Aurobindo Pharma, Barr, Aurobindo, and Mylan Pharms Inc, 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 NDA: 090094

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

Pharmacology for NDA: 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 65862-310-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-310-05)
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

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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