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Details for New Drug Application (NDA): 207027
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: | 8 |
Formulation / Manufacturing: | see details |
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 | 0078-0972 | 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: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Feb 26, 2022 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Regulatory Exclusivity Expiration: | Aug 26, 2021 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY | ||||||||
Patent: | Start Trial | Patent Expiration: | Apr 30, 2019 | Product Flag? | Substance Flag? | Delist Request? |
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 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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