MIDODRINE HYDROCHLORIDE | N019815 | TAKEDA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-5330 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 Midodrine HCl Powder for Oral Solution in 2.5 mg, 5 mg, and 10 mg per packet strengths suitable for submissio | Suitability | 2024-11-14 | Open | Hyman |
Citizen Petition from ALEMBIC PHARMACEUTICALS LIMITED FDA-2019-P-2370 Alembic Pharmaceuticals Limited filed this petition pursuant to 505(j)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine the discontinuation of the Reference Listed Drug Proamtine (Midodrine Hydrochloride Tablets, NDA #019815) was not for safety or effectiveness reason | Other | 2019-05-23 | Denied | ALEMBIC PHARMACEUTICALS LIMITED |
Suitability Petition from Haynes and Boone, LLP FDA-2018-P-1698 Haynes and Boone, LLP filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA determine Midodrine Hydrochloride Oral Solution, 2.5 mg/5 ml, is suitable for submission in an ANDA, with Mylan's Midodrine Hydrochloride Oral Tablets, 5 mg, as the reference listed drug. The petitio | Suitability | 2018-05-02 | Open | Haynes and Boone |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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