DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 207027
NDA 207027 describes PROMACTA KIT, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the PROMACTA KIT profile page.
The generic ingredient in PROMACTA KIT is eltrombopag olamine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
The generic ingredient in PROMACTA KIT is eltrombopag olamine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 207027
| Tradename: | PROMACTA KIT |
| Applicant: | Novartis Pharms Corp |
| 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: | Jun 11, 2018 | ||||||||
| Regulatory Exclusivity Use: | DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH ITP | ||||||||
| Regulatory Exclusivity Expiration: | Jun 11, 2018 | ||||||||
| Regulatory Exclusivity Use: | INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY. | ||||||||
| Regulatory Exclusivity Expiration: | Dec 11, 2018 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Complete Access Available with Subscription
