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Last Updated: September 22, 2020

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Details for New Drug Application (NDA): 076701

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NDA 076701 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, Par Pharm, Rubicon, Torrent, Wockhardt Ltd, 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-eight 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-nine suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 076701
Tradename:LAMOTRIGINE
Applicant:Dr Reddys Labs Ltd
Ingredient:lamotrigine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076701
Suppliers and Packaging for NDA: 076701
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 076701 ANDA Dr.Reddy's Laboratories Limited 55111-225 55111-225-01 100 TABLET, CHEWABLE in 1 BOTTLE (55111-225-01)
LAMOTRIGINE lamotrigine TABLET, CHEWABLE;ORAL 076701 ANDA Dr.Reddy's Laboratories Limited 55111-225 55111-225-05 500 TABLET, CHEWABLE in 1 BOTTLE (55111-225-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Jan 22, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength25MG
Approval Date:Jan 22, 2009TE:ABRLD:No

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