DEXAMETHASONE | A083296 | ALLERGAN HERBERT DIV ALLERGAN INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen petition from Sciarra Laboratories, Inc FDA-2018-P-1719 On behalf of TBD Pharma, LLC, Sciarra Laboratories, Inc. submitted a citizen petition pursuant to 21 CFR 10.30 requesting that the FDA designate Aeroseb-Dex (Dexamethasone Topical Aerosol, 0.01%) ANDA 083296 as a Reference Listed Drug (RLD) in the Orange Book to enable submission of generic ANDA app | 505(q) | 2018-05-02 | Withdrawn | Sciarra Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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