DICYCLOMINE HYDROCHLORIDE | A084285 | LANNETT CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7006 The law firm Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Dicyclomine Hydrochloride Tablets, 10 mg, suitable for submission as an ANDA, with the reference listed drug being Allerga | Suitability | 2025-12-12 | Open | Hyman |
Suitability Petition from Rising Pharma Holdings, Inc. FDA-2024-P-5783 Rising Pharma Holdings, Inc. submitted this suitability petition under section 502(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR section 314.93 requesting FDA approval to file an Abbreviated New Drug Application for Dicyclomine Hydrochloride Capsules USP in 20 mg and 40 mg strength | Suitability | 2024-12-17 | Open | Rising Pharma Holdings |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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