SINEMET

FDA-2025-P-1162

Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Carbidopa and Levodopa Tablets in 37.5 mg/150 mg and 25 mg/150 mg strengths suitable for submission as an ANDA, w

FDA-2020-P-1653

Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Carbidopa and Levodopa Tablets 25 mg/250 mg (ANDA 078536) of Sun Pharmaceutical Industries, Inc. as a new reference standard for conducting in viv

FDA-2020-P-0129

On January 8, 2020, the law firm Hyman, Phelps & McNamara filed a citizen petition with the FDA requesting that the agency designate ANDA 074260 held by Actavis Elizabeth LLC or another appropriate ANDA as a new reference standard for Carbidopa and Levodopa Tablets in strengths of 25 mg/250 mg, 25 m

FDA-1995-P-0005

Athena Neurosciences, Inc. filed this citizen petition on April 11, 1995, requesting approval under 21 CFR 314.93 to submit an abbreviated new drug application for carbidopa/levodopa powder for reconstitution to an oral liquid, a dosage form not identical to the reference listed drug Sinemet tablets