CARBINOXAMINE MALEATE | A040442 | GENUS LIFESCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-4934 Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Carbinoxamine Maleate Tablets, 3 mg, suitable for submission as an Abbreviated New Drug Application, with t | Suitability | 2024-10-23 | Open | Hyman |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-1788 Pharmobedient Consulting, LLC filed this 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 Carbinoxamine Maleate Tablets, 2 mg suitable for submission in an Abbreviated New Drug Application, with t | Suitability | 2024-04-11 | Open | Pharmobedient Consulting |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4283 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Carbinoxamine Maleate Orally Disintegrating Tablets 4 mg suitable for submission in an ANDA, with the proposed dosage | Suitability | 2023-10-03 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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