FLUOXETINE HYDROCHLORIDE | A076237 | BARR LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2018-P-1853 · 4 docket documents Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) and 21 CFR 10.25(a), 10.30, and 314.93 requesting that the FDA designate Dr Reddys Laboratories Ltd.'s Fluoxetine Delayed-Release Capsules USP, 90 mg (ANDA 078572) as an alternative reference standard for conducting bioequiv | 505(q) | 2018-05-11 | Open | Aurobindo Pharma USA, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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