FLUOXETINE HYDROCHLORIDE | A078572 | DR REDDYS LABORATORIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2018-P-1853 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
$30.55
per ea
Lowest NADAC/Unit
$30.55
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 55111028448FLUOXETINE DR 90 MG CAPSULE | $30.55 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.