Details for New Drug Application (NDA): 022291
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The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 022291
Tradename: | PROMACTA |
Applicant: | Novartis |
Ingredient: | eltrombopag olamine |
Patents: | 6 |
Pharmacology for NDA: 022291
Suppliers and Packaging for NDA: 022291
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291 | NDA | Novartis Pharmaceuticals Corporation | 0078-0684 | 0078-0684-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15) |
PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291 | NDA | Novartis Pharmaceuticals Corporation | 0078-0685 | 0078-0685-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0685-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG ACID | ||||
Approval Date: | Nov 20, 2008 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Nov 16, 2025 | ||||||||
Regulatory Exclusivity Use: | INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 13, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 1, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 022291
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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