FLUOXETINE HYDROCHLORIDE | N202133 | TWI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Citizen Petition from Sunny Pharmtech Inc FDA-2019-P-0726 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 | Open | Sunny Pharmtech Inc |
Citizen Petition from Jubilant Generics Limited FDA-2017-P-2128 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 | Open | Jubilant Generics Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.