LOPERAMIDE HYDROCHLORIDE | A072741 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2023-P-4873 The law firm 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 Loperamide HCl Capsules in 1 mg and 4 mg strengths suitable for submission as an Abbreviated New Drug Application, with Johns | Suitability | 2023-11-03 | Open | HYMAN |
Suitability Petition from Hyman, Phelps & McNamara, PC FDA-2020-P-1730 The law firm Hyman, Phelps & McNamara, P.C., 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 FDA declare Loperamide HCl Capsules in 1 mg and 4 mg strengths suitable for submissio | Suitability | 2020-08-04 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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