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drug Glucotrol (glipizide) tablets 5 mg and 10 mg, approved under NDA 017783 by Pfizer Inc., was not discontinued or withdrawn for safety or effectiv | 505(q) | 2024-01-05 | Denied | Graviti Pharmaceuticals Private Limited |
Suitability Petition Completeness Assessment Correspondence from FDA CDER to ... FDA-2023-P-4443 Hyman, Phelps & McNamara, P.C. filed a suitability petition under 21 C.F.R. §314.93(b) requesting permission to submit an Abbreviated New Drug Application for Glipizide Tablets, 15 mg, and the FDA determined the petition was complete with a review goal date of April 23, 2024, under the Generic Drugs | Suitability | 2023-10-23 | Granted | — |
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 | Granted | HYMAN, PHELPS & MCNAMARA, P.C. |
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0939 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whether Glucotrol (glipizide) Tablets, 2.5 mg, approved under NDA 017783 and held by Pfizer Inc., was voluntarily withdrawn | Other | 2021-08-26 | Denied | Hyman, Phelps & McNamara, P.C. |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.