Details for New Drug Application (NDA): 220073
✉ Email this page to a colleague
NDA 220073 describes ELIQUIS SPRINKLE, which is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ELIQUIS SPRINKLE profile page.
The generic ingredient in ELIQUIS SPRINKLE is apixaban. There are thirty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the apixaban profile page.
The generic ingredient in ELIQUIS SPRINKLE is apixaban. There are thirty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the apixaban profile page.
Summary for 220073
| Tradename: | ELIQUIS SPRINKLE |
| Applicant: | Bristol |
| Ingredient: | apixaban |
| Patents: | 2 |
Pharmacology for NDA: 220073
| Mechanism of Action | Factor Xa Inhibitors |
Suppliers and Packaging for NDA: 220073
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELIQUIS SPRINKLE | apixaban | FOR SUSPENSION;ORAL | 220073 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0898 | 0003-0898-28 | 28 CAPSULE in 1 BOTTLE (0003-0898-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 0.15MG | ||||
| Approval Date: | Apr 17, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 17, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Oct 17, 2028 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | May 22, 2041 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Complete Access Available with Subscription
