Viewing data from:

CHLOR-TRIMETON

NDA

CHLORPHENIRAMINE MALEATE | N007638 | BAYER HEALTHCARE LLC

2 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs8 inactive

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

KONGO CHEMICAL CO LTDCHLORPHENIRAMINE MALEATE USP

DMF 38851980

KESHAVA ORGANICS PVT LTDCHLORPHENIRAMINE MALEATE

DMF 213562008

SUPRIYA LIFESCIENCE LTDCHLORPHENIRAMINE MALEATE USP

DMF 222102008

MALLADI DRUGS AND PHARMACEUTICALS LTDCHLORPHENIRAMINE MALEATE

DMF 339442019

KV PHARMACEUTICAL COInactiveCHLORPHENIRAMINE MALEATE 12 MG SRC

DMF 22781974

SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORPInactiveCHLORPHENIRAMINE MALEATE

DMF 39351980

SCHERING PLOUGH AVONDALE COInactiveCHLORPHENIRAMINE MALEATE

DMF 43051981

SANDOZ PHARM CORPInactiveCHLORPHENIRAMINE MALEATE

DMF 53861984

FUKUZYU PHARMACEUTICAL CO LTDInactiveCHLORPHENIRAMINE MALEATE

DMF 60331985

HEXAGON LABORATORIES INCInactiveCHLORPHENIRAMINE MALEATE USP

DMF 63051986

PENCO OF LYNDHURST INCInactiveCHLORPHENIRAMINE MALEATE

DMF 78791989

GRANULES INDIA LTDInactiveChlorpheniramine Maleate USP

DMF 210032007

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2015	SUPPL -38	View Letter (PDF)
Feb 7, 2008	SUPPL -33	View Letter (PDF)
Jan 30, 2006	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982