CARBIDOPA; LEVODOPA | N017555 | ORGANON LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. 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 | Suitability | 2025-05-09 | Open | Hyman |
Citizen Petition from Aurobindo Pharma USA, Inc. 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078536) of Sun Pharmaceutical Industries, Inc. as a new reference standard for conducting in viv | Other | 2020-07-13 | Withdrawn | Aurobindo Pharma USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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