CARBINOXAMINE MALEATE | N022556 | AYTU BIOSCIENCE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 - Carbinoxamine Maleate Orange Book_ Approved Drug Products with... FDA-2023-P-4321 · 12 docket documents Newcastle Bioscience LLC filed a suitability petition regarding carbinoxamine maleate, an antihistamine drug product listed in the FDA's Orange Book of approved drug products with therapeutic equivalence evaluations. The petition addresses questions concerning the suitability of carbinoxamine maleat | Suitability | 2023-10-05 | Granted | Newcastle Bioscience LLC |
Attachment 2 CARBINOXAMINE MALEATE re Suitability Petition from Pharmobedient... FDA-2023-P-4283 · 8 docket documents Pharmobedient Consulting, LLC filed a suitability petition regarding carbinoxamine maleate, requesting FDA evaluation of the drug's suitability for abbreviated new drug application (ANDA) development to support generic drug manufacturing. | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting, LLC |
Attachment 2 - CARBINOXZAMINE MALEATE- carbinoxamine maleate solution RE Suit... FDA-2023-P-4322 · 7 docket documents Pharmobedient Consulting, LLC filed a suitability petition regarding carbinoxamine maleate solution, requesting FDA evaluation of the drug's suitability for inclusion in the ANDA process or establishing appropriate regulatory pathways for generic development. | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting, LLC |
Citizen Petition from Sage Pharmaceuticals FDA-1998-P-0664 · 9 docket documents Sage Pharmaceuticals filed this citizen petition under 21 CFR 314.122(a) and 505(j)(2)(c) requesting that the FDA determine McNeil Laboratories' voluntary withdrawal of its NDA for Clistin® (carbinoxamine maleate 4 mg tablets) was not for safety or effectiveness reasons, thereby allowing Sage to fil | 505(q) | 2017-06-15 | Granted | Sage Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.20
per ml
Lowest NADAC/Unit
$1.05
per ml
Brand NDCs
1
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 23594010105KARBINAL ER 4 MG/5 ML SUSP | $1.20 | ML | Brand | $1.05 | 2026-06-17 |
| 62542010105CARBINOXAMINE ER 4 MG/5 ML SUSP | $1.05 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.