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- Lamotrigine LAMOTRIGINE 100 mg/1 Zydus Lifesciences Limited
Lamotrigine
- Lamotrigine LAMOTRIGINE 100 mg/1 A-S Medication Solutions
- Lamotrigine LAMOTRIGINE 100 mg/1 RPK Pharmaceuticals, Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 Zydus Lifesciences Limited
- Lamotrigine LAMOTRIGINE 100 mg/1 Aurobindo Pharma Limited
- Lamotrigine LAMOTRIGINE 100 mg/1 JUBILANT CADISTA PHARMACEUTICALS INC.
- Lamotrigine LAMOTRIGINE 100 mg/1 Northstar Rx LLC.
- LAMOTRIGINE LAMOTRIGINE 100 mg/1 RPK Pharmaceuticals, Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 NuCare Pharmaceuticals,Inc.
- LAMOTRIGINE LAMOTRIGINE 100 mg/1 Torrent Pharmaceuticals Limited
- Lamotrigine LAMOTRIGINE 100 mg/1 Advagen Pharma Limited
- Lamotrigine LAMOTRIGINE 100 mg/1 Quallent Pharmaceuticals Health LLC
- Lamotrigine LAMOTRIGINE 100 mg/1 REMEDYREPACK INC.
- Lamotrigine LAMOTRIGINE 100 mg/1 REMEDYREPACK INC.
- Lamotrigine LAMOTRIGINE 100 mg/1 Northwind Pharmaceuticals, LLC
- Lamotrigine Extended Release LAMOTRIGINE 100 mg/1 Par Pharmaceutical, Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 Unichem Pharmaceuticals (USA), Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 Amring Pharmaceuticals Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 NuCare Pharmaceuticals,Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 REMEDYREPACK INC.
- Lamotrigine LAMOTRIGINE 100 mg/1 NorthStar Rx LLC
- LAMOTRIGINE LAMOTRIGINE 100 mg/1 DirectRX
- Lamotrigine LAMOTRIGINE 100 mg/1 A-S Medication Solutions
- Lamotrigine LAMOTRIGINE 100 mg/1 Taro Pharmaceuticals U.S.A., Inc.
- LAMICTAL LAMOTRIGINE 100 mg/1 GlaxoSmithKline LLC
- LAMICTAL LAMOTRIGINE 100 mg/1 GlaxoSmithKline LLC
- Lamotrigine LAMOTRIGINE 100 mg/1 NCS HealthCare of KY, Inc dba Vangard Labs
- Lamotrigine LAMOTRIGINE 100 mg/1 Cardinal Health 107, LLC
- Lamotrigine LAMOTRIGINE 100 mg/1 PD-Rx Pharmaceuticals, Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 REMEDYREPACK INC.
- Lamotrigine LAMOTRIGINE 100 mg/1 Bryant Ranch Prepack
- Lamotrigine LAMOTRIGINE 100 mg/1 Alembic Pharmaceuticals Inc.
- LAMOTRIGINE LAMOTRIGINE 100 mg/1 Proficient Rx LP
- LAMOTRIGINE LAMOTRIGINE 100 mg/1 PD-Rx Pharmaceuticals, Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 Alembic Pharmaceuticals Limited
- Lamotrigine LAMOTRIGINE 100 mg/1 Cardinal Health 107, LLC
- Lamotrigine LAMOTRIGINE 100 mg/1 Preferred Pharmaceuticals Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 Aurobindo Pharma Limited
- Lamotrigine LAMOTRIGINE 100 mg/1 A-S Medication Solutions
- Lamotrigine LAMOTRIGINE 100 mg/1 Zydus Pharmaceuticals USA Inc.
- Lamotrigine LAMOTRIGINE 100 mg/1 Major Pharmaceuticals
- Lamotrigine LAMOTRIGINE 100 mg/1 Proficient Rx LP
- Lamotrigine LAMOTRIGINE 100 mg/1 AvKARE
- Lamotrigine LAMOTRIGINE 100 mg/1 Zydus Pharmaceuticals USA Inc.
Summary of product characteristics
Effective Time
20230926
Version
10
Spl Product Data Elements
Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;79 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;90 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;80 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;81 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;82 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;91 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE BLACK CURRANT WHITE TO OFF- WHITE Black Current ROUND Z;13 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE BLACK CURRANT WHITE TO OFF- WHITE Black Current ROUND Z;12
Application Number
ANDA077633
Brand Name
Lamotrigine
Generic Name
Lamotrigine
Product Ndc
65841-684
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lamotrigine Tablets (Chewable, Dispersible), 5 mg NDC 65841-689-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets (Chewable, Dispersible), 5 mg Lamotrigine Tablets (Chewable, Dispersible), 25 mg NDC 65841-690-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets (Chewable, Dispersible), 25 mg Lamotrigine Tablets USP, 25 mg NDC 65841-682-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 25 mg Lamotrigine Tablets USP, 50 mg NDC 65841-683-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 50 mg Lamotrigine Tablets USP, 100 mg NDC 65841-684-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 100 mg Lamotrigine Tablets USP, 150 mg NDC 65841-685-14 in bottle of 60 tablets 60 tablets Rx only Lamotrigine Tablets USP, 150 mg Lamotrigine Tablets USP, 200 mg NDC 65841-686-14 in bottle of 60 tablets 60 tablets Rx only Lamotrigine Tablets USP, 200 mg Lamotrigine Tablets USP, 250 mg NDC 65841-687-05 in bottle of 500 tablets 500 tablets Rx only Lamotrigine Tablets USP, 250 mg Lamotrigine Tablets (Chewable, Dispersible), 5 mg Lamotrigine Tablets (Chewable, Dispersible), 5mg Lamotrigine Tablets (Chewable, Dispersible), 25 mg Lamotrigine Tablets USP, 25 mg Lamotrigine Tablets USP, 50 mg Lamotrigine Tablets USP, 100 mg Lamotrigine Tablets USP, 150 mg Lamotrigine Tablets USP, 200 mg Lamotrigine Tablets USP, 250 mg
Spl Medguide
SPL MEDGUIDE
Drug section
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