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CLISTIN

NDA

CARBINOXAMINE MALEATE | N008955 | MCNEIL PHARMACEUTICAL CO DIV MCNEILAB INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

4 petitions from Regulations.gov

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
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 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.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs4 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

KONGO CHEMICAL CO LTDCARBINOXAMINE MALEATE

DMF 98441992

MSN PHARMACHEM PRIVATE LTDCARBINOXAMINE MALEATE USP [ROUTE CODE - "CX"]

DMF 213012008

SYMED LABS LTDCARBINOXAMINE MALEATE USP

DMF 213352008

R L FINE CHEM PVT LTDCARBINOXAMINE MALEATE

DMF 341102019

TAISHO PHARMACEUTICAL CO LTDInactiveCARBINOXAMINE MALEATE

DMF 29621977

HEINRICH MACK NACHFInactiveCARBINOXAMINE MALEATE

DMF 32071978

HEINRICH MACK NACHFInactiveCARBINOXAMINE MALEATE

DMF 86871990

TAI HENG INDUSTRY CO LTDInactiveCARBINOXAMINE MALEATE API USP

DMF 212832008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 4MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

ELIXIR;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.