PROGESTERONE | N017553 | ALZA CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from DDReg Pharma Inc. FDA-2024-P-0427 · 7 docket documents DDReg Pharma Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA Commissioner determine the reference listed drug for an ANDA of a progesterone-based pessary formulation that differs in dosage form and strength from | Suitability | 2024-01-23 | Denied | DDReg Pharma Inc. |
Duramed Pharmaceuticals, Inc. - Citizen Petition FDA-2001-P-0030 · 8 docket documents Duramed Pharmaceuticals, Inc. submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA permit an Abbreviated New Drug Application for 100 mg and 200 mg progesterone tablet dosage forms bioequivalent to Prometrium Capsules, citing advantag | Other | 2010-03-11 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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