SUMATRIPTAN SUCCINATE | N020132 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-4784 Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare sumatriptan oral solution in 25 mg/5 mL, 50 mg/5 mL, 75 mg/5 mL, and 100 mg/5 mL strengths suitable for submis | Suitability | 2023-10-30 | Open | Hyman |
Attachment 2 - IMITREX- sumatriptan tablet, film coated RE Suitability Petiti... FDA-2023-P-4784 Hyman, Phelps & McNamara, P.C. filed a citizen petition regarding IMITREX (sumatriptan tablet, film coated) requesting a determination of suitability, likely under 21 CFR 314.80 or related regulatory provisions governing the appropriateness of the drug product formulation or manufacturing process fo | Suitability | 2023-10-30 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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