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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 207497


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NDA 207497 describes LAMOTRIGINE, which is a drug marketed by Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Mylan, 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, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in forty-nine NDAs. It is available from fifty 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-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 207497
Tradename:LAMOTRIGINE
Applicant:Amneal Pharms
Ingredient:lamotrigine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207497
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 207497 ANDA AvKARE 42291-443 42291-443-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-443-30)
LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 207497 ANDA AvKARE 42291-444 42291-444-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-444-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Nov 30, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Nov 30, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Nov 30, 2018TE:ABRLD:No

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