PREDNISOLONE ACETATE | A216935 | LUPIN LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from DifGen Pharmaceuticals LLC FDA-2024-P-5583 · 4 docket documents DifGen Pharmaceuticals LLC filed a citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require long-term stability studies at refrigerated conditions (5°C ± 3°C) for any ANDA approvals of Prednisolone Ophthalmic Solution 1%, and further req | 505(q) | 2024-12-03 | Denied | DifGen Pharmaceuticals LLC |
Citizen Petition from DifGen Pharmaceuticals LLC FDA-2024-P-5254 · 4 docket documents DifGen Pharmaceuticals LLC filed a citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any Abbreviated New Drug Application (ANDA) for Prednisolone Ophthalmic Solution 1% without long-term stability studies conducted | 505(q) | 2024-11-13 | Withdrawn | DifGen Pharmaceuticals LLC |
Citizen Petition from Raaha LLC FDA-2024-P-3799 · 5 docket documents Raaha LLC filed a citizen petition under section 505(j)(2)(C) requesting that the FDA refrain from approving any ANDA for Prednisolone Ophthalmic Solution 1% without long-term stability studies conducted at refrigerated conditions of 5°C ± 3°C, and requesting that the FDA revisit the June 2, 2024 ap | 505(q) | 2024-08-09 | Withdrawn | Raaha LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$4.58
per ml
Lowest NADAC/Unit
$3.93
per ml
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70748033202PREDNISOLONE AC 1% EYE DROP | $4.58 | ML | Generic | — | 2026-06-17 |
| 70748033203PREDNISOLONE AC 1% EYE DROP | $4.58 | ML | Generic | — | 2026-06-17 |
| 70748033204PREDNISOLONE AC 1% EYE DROP | $3.93 | ML | 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.