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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 211821


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NDA 211821 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Alembic, Amneal Pharms, Dr Reddys Labs Ltd, Endo Operations, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Granules, Hikma Pharms, Ipca Labs, Jubilant Cadista, Lupin Ltd, Natco Pharma, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in fifty-one NDAs. It is available from fifty-two suppliers. Additional details are available on the LAMOTRIGINE profile page.

The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 211821
Tradename:LAMOTRIGINE
Applicant:Alembic
Ingredient:lamotrigine
Patents:0
Suppliers and Packaging for NDA: 211821
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 211821 ANDA Alembic Pharmaceuticals Limited 46708-417 46708-417-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-417-30)
LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 211821 ANDA Alembic Pharmaceuticals Limited 46708-417 46708-417-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-417-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Oct 1, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength250MG
Approval Date:Oct 1, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Oct 1, 2024TE:ABRLD:No

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