GLIPIZIDE | N017783 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Graviti Pharmaceuticals Private Limited FDA-2024-P-0105 Graviti Pharmaceuticals Private Limited filed this citizen petition on January 3, 2024, requesting that the FDA determine whether the reference listed drug Glucotrol (glipizide) tablets 5 mg and 10 mg, approved under NDA 017783 by Pfizer Inc., was not discontinued or withdrawn for safety or effectiv | 505(q) | 2024-01-05 | Withdrawn | Graviti Pharmaceuticals Private Limited |
SUITABILITY PETITION from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2023-P-4443 Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Glipizide Tablets, 15 mg (scored), suitable for submission as an Abbreviated New | Suitability | 2023-10-11 | Open | HYMAN |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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