FLUOXETINE HYDROCHLORIDE | A078572 | DR REDDYS LABORATORIES LTD
| 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.
Highest NADAC/Unit
$30.58
per ea
Lowest NADAC/Unit
$30.58
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 55111028448FLUOXETINE DR 90 MG CAPSULE | $30.58 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.