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FDA Drug information

LENALIDOMIDE

Read time: 1 mins
Marketing start date: 26 Nov 2024
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Summary of product characteristics


Effective Time

20230307

Version

2

Spl Product Data Elements

LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERROSOFERRIC OXIDE GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POTASSIUM HYDROXIDE SHELLAC TITANIUM DIOXIDE white opaque cap with white opaque body capsule 1031 LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C RED NO. 33 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POTASSIUM HYDROXIDE SHELLAC TITANIUM DIOXIDE White opaque cap Turquoise blue opaque body capsule 1032 LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C RED NO. 28 FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POTASSIUM HYDROXIDE SHELLAC TITANIUM DIOXIDE White opaque cap Light Blue opaque body capsule 1033 LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C RED NO. 28 FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POTASSIUM HYDROXIDE SHELLAC TITANIUM DIOXIDE White opaque cap Light Blue opaque body capsule 1035 LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 FERROSOFERRIC OXIDE GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POTASSIUM HYDROXIDE SHELLAC TITANIUM DIOXIDE white opaque cap with blue opaque body capsule 1030 LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE LENALIDOMIDE ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C RED NO. 28 D&C RED NO. 33 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE POTASSIUM HYDROXIDE SHELLAC TITANIUM DIOXIDE light blue opaque cap turquoise blue opaque body capsule 1034

Application Number

ANDA210154

Brand Name

LENALIDOMIDE

Generic Name

LENALIDOMIDE

Product Ndc

70771-1677

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1676-7 Lenalidomide Capsules, 2.5 mg 28 Capsules Rx only NDC 70771-1677-7 Lenalidomide Capsules, 5 mg 28 Capsules Rx only NDC 70771-1678-7 Lenalidomide Capsules, 10 mg 28 Capsules Rx only NDC 70771-1679-8 Lenalidomide Capsules, 15 mg 21 Capsules Rx only NDC 70771-1680-8 Lenalidomide Capsules, 20 mg 21 Capsules Rx only NDC 70771-1681-8 Lenalidomide Capsules, 25 mg 21 Capsules Rx only 2.5 mg label 5 mg label 10 mg label 15 mg label 20 mg label 25 mg label

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