ALBUTEROL SULFATE | A075050 | BAUSCH HEALTH US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from RegCon Solutions, LLC. FDA-2018-P-1751 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.
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