Details for New Drug Application (NDA): 209348
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The generic ingredient in LENALIDOMIDE is lenalidomide. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 209348
Tradename: | LENALIDOMIDE |
Applicant: | Dr Reddys |
Ingredient: | lenalidomide |
Patents: | 0 |
Suppliers and Packaging for NDA: 209348
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 209348 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-511 | 43598-511-01 | 100 CAPSULE in 1 BOTTLE (43598-511-01) |
LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 209348 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-511 | 43598-511-63 | 28 CAPSULE in 1 BOTTLE (43598-511-63) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
Approval Date: | Oct 14, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 14, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 30, 2022 | TE: | AB | RLD: | No |
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