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Details for New Drug Application (NDA): 091338

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Summary for NDA: 091338

Torrent Pharms Ltd
Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 091338

Suppliers and Packaging for NDA: 091338

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, EXTENDED RELEASE;ORAL 091338 ANDA Torrent Pharmaceuticals Limited 13668-272 13668-272-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-272-05)
TABLET, EXTENDED RELEASE;ORAL 091338 ANDA Torrent Pharmaceuticals Limited 13668-272 13668-272-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-272-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:May 29, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:May 29, 2012TE:ABRLD:No

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