CARBINOXAMINE MALEATE | A040458 | GENUS LIFESCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience LLC FDA-2023-P-4321 · 12 docket documents Newcastle Bioscience LLC filed this suitability petition requesting FDA approval to pursue an ANDA for Carbinoxamine Maleate Orally Disintegrating Tablets in 2 mg, 4 mg, 6 mg, and 8 mg strengths, using the reference listed drug Carbinoxamine Maleate Oral Solution 4 mg/5 ml as the basis for the chang | Suitability | 2023-10-05 | Granted | Newcastle Bioscience LLC |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4322 · 7 docket documents Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the FDC Act requesting FDA approval to submit an ANDA for Carbinoxamine Maleate Powder for Solution in 2 mg and 4 mg sachets, which differs in dosage form from the reference listed drug CLISTIN oral solution | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting, LLC |
Citizen Petition from Lachman Consultant Services Inc FDA-2016-P-4164 · 6 docket documents Lachman Consultant Services Inc filed this petition on behalf of a client requesting that the FDA declare Carbinoxamine Maleate Orally Disintegrating Tablets in strengths of 2 mg, 4 mg, 6 mg, and 8 mg suitable for submission as an Abbreviated New Drug Application, with a reference to the approved Ca | Other | 2016-12-02 | Denied | Lachman Consultant Services Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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