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Last Updated: April 12, 2021

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Details for New Drug Application (NDA): 200672

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NDA 200672 describes LAMOTRIGINE, which is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Atlantide, Par Pharm, Rubicon, Torrent, Zydus Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Celltrion, Cipla, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, and Zydus Pharms Usa, and is included in forty-seven NDAs. It is available from forty-six 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. Forty-seven suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 200672
Tradename:LAMOTRIGINE
Applicant:Actavis Elizabeth
Ingredient:lamotrigine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200672
Suppliers and Packaging for NDA: 200672
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 200672 ANDA Actavis Pharma, Inc. 0228-1410 0228-1410-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1410-03)
LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 200672 ANDA Actavis Pharma, Inc. 0228-1422 0228-1422-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-1422-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Oct 17, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Oct 17, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Oct 17, 2013TE:ABRLD:No

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