Details for New Drug Application (NDA): 207027
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The generic ingredient in PROMACTA KIT 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 207027
Tradename: | PROMACTA KIT |
Applicant: | Novartis |
Ingredient: | eltrombopag olamine |
Patents: | 1 |
Pharmacology for NDA: 207027
Suppliers and Packaging for NDA: 207027
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027 | NDA | Novartis Pharmaceuticals Corporation | 0078-0697 | 0078-0697-61 | 1 CARTON in 1 KIT (0078-0697-61) / 30 PACKET in 1 CARTON (0078-0697-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19) |
PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027 | NDA | Novartis Pharmaceuticals Corporation | 0078-0972 | 0078-0972-61 | 1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 25MG ACID/PACKET | ||||
Approval Date: | Aug 24, 2015 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Nov 16, 2025 | ||||||||
Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 13, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 12.5MG ACID/PACKET | ||||
Approval Date: | Sep 27, 2018 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Nov 16, 2025 | ||||||||
Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
Expired US Patents for NDA 207027
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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