PROAMATINE

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

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

FDA-2018-P-1698

Haynes and Boone LLP filed a petition regarding Mylan's midodrine hydrochloride product, requesting FDA action on labeling suitability for the drug. The petition addresses regulatory concerns related to the product's approved labeling and seeks FDA review under established mechanisms governing gener

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

FDA-2013-P-0027

Custo Pharm Inc filed this citizen petition requesting that the FDA amend the Orange Book to designate Impax Pharmaceutical's Midodrine Hydrochloride Tablets, ANDA 076449, as the reference listed drug for midodrine hydrochloride tablets 5 mg, since the previous reference listed drug Proamatine (NDA