Details for New Drug Application (NDA): 220250
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The generic ingredient in ELTROMBOPAG OLAMINE is eltrombopag olamine. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 220250
| Tradename: | ELTROMBOPAG OLAMINE |
| Applicant: | Msn |
| Ingredient: | eltrombopag olamine |
| Patents: | 0 |
Pharmacology for NDA: 220250
Suppliers and Packaging for NDA: 220250
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELTROMBOPAG OLAMINE | eltrombopag olamine | TABLET;ORAL | 220250 | ANDA | Novadoz Pharmaceuticals LLC | 72205-156 | 72205-156-30 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-156-30) |
| ELTROMBOPAG OLAMINE | eltrombopag olamine | TABLET;ORAL | 220250 | ANDA | Novadoz Pharmaceuticals LLC | 72205-157 | 72205-157-30 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-157-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12.5MG ACID | ||||
| Approval Date: | Jan 14, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG ACID | ||||
| Approval Date: | Jan 14, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG ACID | ||||
| Approval Date: | Jan 14, 2026 | TE: | AB | RLD: | No | ||||
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