FLUOXETINE HYDROCHLORIDE | A075755 | RISING PHARMA HOLDING INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services Inc FDA-2015-P-1899 · 5 docket documents Lachman Consultant Services Inc filed this petition on May 22, 2015 pursuant to Section 505(b) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Fluoxetine Hydrochloride Tablets 60 mg (NDA 202133) held by Edgemont Pharmaceuticals LLC as a second reference-listed drug to e | 505(q) | 2015-05-29 | Granted | Lachman Consultant Services Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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