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FDA Drug information

Lamotrigine

Read time: 1 mins
Marketing start date: 28 May 2024

Summary of product characteristics


Effective Time

20231003

Version

4

Spl Product Data Elements

Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT YELLOW TO YELLOW ROUND 979 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 FD&C BLUE NO. 2 FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT GREEN TO GREEN ROUND 980 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 D&C RED NO. 27 FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT ORANGE TO ORANGE ROUND 981 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT BLUE TO BLUE ROUND 982 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER CARMINIC ACID LIGHT PURPLE TO PURPLE OVAL 983 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER FERRIC OXIDE YELLOW LIGHT GRAY TO GRAY OVAL 984

Application Number

ANDA207763

Brand Name

Lamotrigine

Generic Name

Lamotirigine

Product Ndc

70771-1515

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1514-3 Lamotrigine extended-release tablets, 25 mg Rx only 30 tablets NDC 70771-1515-3 Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 Lamotrigine extended-release tablets, 300 mg Rx only 30 tablets 25 mg label 50 mg label 100 mg label 200 mg label 250 mg label 300 mg label

Spl Medguide

SPL MEDGUIDE

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