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- LENALIDOMIDE LENALIDOMIDE 15 mg/1 Zydus Lifesciences Limited
LENALIDOMIDE
- LENALIDOMIDE LENALIDOMIDE 15 mg/1 Zydus Pharmaceuticals USA Inc.
- Lenalidomide LENALIDOMIDE 15 mg/1 Aurobindo Pharma Limited
- Lenalidomide LENALIDOMIDE 15 mg/1 Apotex Corp.
- Lenalidomide LENALIDOMIDE 15 mg/1 Mylan Pharmaceuticals Inc.
- Lenalidomide LENALIDOMIDE 15 mg/1 Apotex Corp.
- Lenalidomide LENALIDOMIDE 15 mg/1 Dr. Reddy's Laboratories Inc.
- Lenalidomide LENALIDOMIDE 15 mg/1 Mylan Pharmaceuticals Inc.
- Revlimid LENALIDOMIDE 15 mg/1 Celgene Corporation
- LENALIDOMIDE LENALIDOMIDE 15 mg/1 Zydus Lifesciences Limited
- Lenalidomide LENALIDOMIDE 15 mg/1 Cipla USA Inc.
- LENALIDOMIDE LENALIDOMIDE 15 mg/1 Zydus Pharmaceuticals USA Inc.
- LENALIDOMIDE LENALIDOMIDE 15 mg/1 Camber Pharmaceuticals, Inc.
- Lenalidomide LENALIDOMIDE 15 mg/1 Sun Pharmaceutical Industries, Inc.
- Lenalidomide LENALIDOMIDE 15 mg/1 Aurobindo Pharma Limited
- LENALIDOMIDE LENALIDOMIDE 15 mg/1 Zydus Lifesciences Limited
- LENALIDOMIDE LENALIDOMIDE 15 mg/1 Alvogen, Inc.
Summary of product characteristics
Effective Time
20230927
Version
3
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
70771-1679
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
Spl Medguide
SPL MEDGUIDE
Drug section
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