CEFDINIR | A065337 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from ApicHope Pharmaceuticals (USA) Limited FDA-2022-P-0833 · 4 docket documents ApicHope Pharmaceutical (USA) Limited filed this citizen petition on May 18, 2022, requesting that the FDA determine whether the reference standard cefdinir powder for suspension (125 mg/5 mL and 250 mg/5 mL) manufactured by Sandoz under ANDA 065337 was discontinued or withdrawn for safety or effect | 505(q) | 2022-05-18 | Withdrawn | ApicHope Pharmaceuticals (USA) Limited |
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2013-P-0947 · 4 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate an additional Reference Listed Drug for Cefdinir for Oral Suspension in the Orange Book, because the original RLD (OMN | 505(q) | 2013-09-16 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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