SUMATRIPTAN | N020626 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 |
Attachment 3 - Sumatriptan oral solution RE Suitability Petition from Hyman, ... FDA-2023-P-4784 Hyman, Phelps & McNamara, P.C. filed a petition regarding the suitability of sumatriptan oral solution, requesting that the FDA make a determination about whether this formulation is appropriate for development and approval as a drug product under the NDA or ANDA pathway. | Suitability | 2023-10-30 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.