ZEBETA

FDA-2024-P-4159

The law firm 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 Bisoprolol Fumarate Tablets, 1.25 mg, suitable for submission as an Abbreviated New Drug Appli

FDA-2023-P-4874

Hyman, Phelps, & McNamara, P.C. filed a suitability petition regarding ZEBETA bisoprolol tablets. The petition requests FDA determination of the suitability of the drug product for abbreviated new drug application approval under 505(j) of the Federal Food, Drug, and Cosmetic Act.

FDA-2023-P-4874

Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Bisoprolol Tablets in 2.5 mg and 7.5 mg strengths suitable for submission of an Abbreviated New Drug Application, with ZEBETA (bisoprolol

FDA-2021-P-0125

The law firm Hyman, Phelps & McNamara filed this suitability petition on behalf of a client 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 Bisoprolol Tablets in 2.5 mg and 7.5 mg strengths suitable for submission as

FDA-2021-P-0037

The law firm Hyman, Phelps & McNamara PC filed this suitability petition on behalf of a client under 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 Bisoprolol Tablets in 2.5 mg (unscored) and 7.5 mg (scored) strengths suitable