DEXAMETHASONE | A083296 | ALLERGAN HERBERT DIV ALLERGAN INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen petition from Sciarra Laboratories, Inc FDA-2018-P-1719 · 7 docket documents 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as a Reference Listed Drug (RLD) in the Orange Book to enable submission of generic ANDA app | 505(q) | 2018-05-02 | Withdrawn | Sciarra Laboratories, Inc |
Citizens Petition from Acaderm Inc. FDA-2005-P-0394 · 6 docket documents Acaderm Inc. filed this citizen petition under 21 CFR 10.30 and 21 CFR 314.161 requesting that the FDA Commissioner determine whether Aeroseb-Dex (Dexamethasone) Topical Aerosol 0.01% (NDA 083-296) by Allergan Herbert was voluntarily withdrawn from sale for safety or efficacy reasons, as this determ | Other | 2011-02-09 | Granted | Acaderm Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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