ALBUTEROL SULFATE | A075664 | NEPHRON CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from RegCon Solutions, LLC. FDA-2018-P-1751 · 5 docket documents RegCon Solutions, LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Nephron Corp.'s Albuterol Sulfate Inhalation Solution, 2.5 mg/0.5 mL (0.5% base), ANDA 075664, as a Reference Standard to enab | 505(q) | 2018-05-04 | Granted | RegCon Solutions, LLC. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.5281
per ea
Lowest NADAC/Unit
$0.5281
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00487990130ALBUTEROL 2.5 MG/0.5 ML SOL | $0.5281 | EA | Generic | — | 2026-06-17 |
| 62135082984ALBUTEROL 2.5 MG/0.5 ML SOL | $0.5281 | EA | Generic | — | 2026-06-17 |
| 64980064203ALBUTEROL 2.5 MG/0.5 ML SOL | $0.5281 | 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.