CARBINOXAMINE MALEATE | N022556 | AYTU BIOSCIENCE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 Carbinoxamine Maleate Approved Labeling re Suitability Petition ... FDA-2023-P-4321 Newcastle Bioscience LLC filed a citizen petition regarding carbinoxamine maleate, requesting FDA evaluation of the suitability of the approved labeling for this antihistamine drug product. The petition seeks confirmation that the existing approved labeling meets current regulatory standards and req | Suitability | 2023-10-05 | Granted | Newcastle Bioscience LLC |
Attachment 1 - Carbinoxamine Maleate Orange Book_ Approved Drug Products with... FDA-2023-P-4321 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 3 - CARBINOXZAMINE MALEATE- carbinoxamine maleate powder RE Suitab... FDA-2023-P-4322 Pharmobedient Consulting, LLC filed a suitability petition regarding carbinoxamine maleate powder, requesting FDA evaluation of the drug substance's suitability for use in pharmaceutical applications under the agency's established regulatory framework for drug substance acceptability determinations. | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting, LLC |
Attachment 3 CARBINOXAMINE MALEATE re Suitability Petition from Pharmobedient... FDA-2023-P-4283 Pharmobedient Consulting LLC filed a citizen petition requesting that the FDA establish suitability findings for carbinoxamine maleate, enabling the use of this active pharmaceutical ingredient in abbreviated new drug applications (ANDAs) for generic drug products. | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting LLC |
Attachment 2 - CARBINOXZAMINE MALEATE- carbinoxamine maleate solution RE Suit... FDA-2023-P-4322 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 |
Attachment 2 CARBINOXAMINE MALEATE re Suitability Petition from Pharmobedient... FDA-2023-P-4283 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 4 Draft Guidance for CARBINOXAMINE MALEATE re Suitability Petition... FDA-2023-P-4283 Pharmobedient Consulting, LLC filed a suitability petition regarding carbinoxamine maleate, requesting FDA guidance on the drug substance's suitability for use in pharmaceutical formulations and generic drug applications. | Suitability | 2023-10-03 | Denied | Pharmobedient Consulting, LLC |
Citizen Petition from Sage Pharmaceuticals FDA-1998-P-0664 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
$1.19
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 | $1.19 | ML | Brand | $1.05 | 2026-10-21 |
| 62542010105CARBINOXAMINE ER 4 MG/5 ML SUSP | $1.05 | ML | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.