CARBINOXAMINE MALEATE | A040442 | GENUS LIFESCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-1788 · 8 docket documents Pharmobedient Consulting, LLC filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Carbinoxamine Maleate Tablets, 2 mg suitable for submission in an Abbreviated New Drug Application, with t | Suitability | 2024-04-11 | Open | Pharmobedient Consulting, LLC |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4283 · 8 docket documents Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Carbinoxamine Maleate Orally Disintegrating Tablets 4 mg suitable for submission in an ANDA, with the proposed dosage | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4344
per ea
Lowest NADAC/Unit
$0.4344
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 64950021101CARBINOXAMINE MALEATE 4 MG TAB | $0.4344 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.