ESOMEPRAZOLE MAGNESIUM | N021957 | ASTRAZENECA PHARMACEUTICALS LP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Foley & Lardner, LLP FDA-2019-P-5691 Foley & Lardner LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that an Abbreviated New Drug Application may be submitted for esomeprazole magnesium delayed-release capsules in 2.5 mg, 5 mg | Suitability | 2019-12-04 | Open | Foley & Lardner |
Citizen Petition from Sandoz, Inc. FDA-2012-P-0661 Sandoz, Inc. filed this petition requesting that the FDA issue a written decision holding that the first applicant to submit a Paragraph IV ANDA for a generic version of NEXIUM (esomeprazole magnesium) Delayed Release Capsules has forfeited its 180-day exclusivity rights under 21 U.S.C. § 355(j)(5)( | 505(q) | 2012-06-25 | Denied | Sandoz |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.