DABIGATRAN ETEXILATE MESYLATE | N214358 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lupin, Inc. FDA-2024-P-0526 · 10 docket documents Lupin, Inc. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Apixaban Oral Suspension, 1.25 mg/mL suitable for consideration in an ANDA, with the reference drug product being ELIQUIS (apixaban) Tablets by Bri | Suitability | 2024-01-26 | Denied | Lupin, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7932273 | Sep 7, 2025PED: Mar 7, 2026 | PED | Yes | Yes | — | — |