GLIPIZIDE | N017783 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Graviti Pharmaceuticals Private Limited FDA-2024-P-0105 · 7 docket documents 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drug Glucotrol (glipizide) tablets 5 mg and 10 mg, approved under NDA 017783 by Pfizer Inc., was not discontinued or withdrawn for safety or effectiv | 505(q) | 2024-01-05 | Denied | Graviti Pharmaceuticals Private Limited |
SUITABILITY PETITION from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2023-P-4443 · 7 docket documents 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 | Granted | HYMAN, PHELPS & MCNAMARA, P.C. |
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0939 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Glucotrol (glipizide) Tablets, 2.5 mg, approved under NDA 017783 and held by Pfizer Inc., was voluntarily withdrawn | Other | 2021-08-26 | Denied | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.