FLUOXETINE HYDROCHLORIDE | N202133 | TWI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Citizen Petition from Sunny Pharmtech Inc FDA-2019-P-0726 · 7 docket documents Sunny Pharmtech Inc. submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval that Fluoxetine Hydrochloride 20 mg is suitable for submission as an ANDA, seeking to add a 20 mg strength to the reference listed drug Fluoxetine Hydr | Suitability | 2019-02-14 | Denied | Sunny Pharmtech Inc |
Citizen Petition from Jubilant Generics Limited FDA-2017-P-2128 · 6 docket documents Jubilant Generics Limited filed this citizen petition pursuant to section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine Fluoxetine Hydrochloride Tablets in 30 mg and 40 mg strengths are suitable for submission as an ANDA, with the reference listed drug bei | Other | 2017-04-05 | Withdrawn | Jubilant Generics Limited |
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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