CARBINOXAMINE MALEATE | A040458 | GENUS LIFESCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience LLC FDA-2023-P-4321 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 | Open | Newcastle Bioscience LLC |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4322 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 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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