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NDA

CARISOPRODOL | N012155 | SCHERING CORP SUB SCHERING PLOUGH CORP

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition A from Biopharmaceutics, Inc. FDA-1988-P-0040 · 5 docket documents Biopharmaceutics, Inc. filed this citizen petition under 21 U.S.C. Section 505(j)(2)(A) and (C) requesting that the FDA find the combination drug Carisoprodol 200mg and Acetaminophen 325mg suitable for abbreviated new drug application approval, arguing that Acetaminophen can substitute for Aspirin i	Other	2017-06-28	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back NCT00671502	Phase 3	Completed	Meda Pharmaceuticals	840	2008-04 → 2009-02
Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back NCT00671879	Phase 3	Completed	Meda Pharmaceuticals	830	2008-04 → 2009-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs10 inactive

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

OLON SPACARISOPRODOL

DMF 44161982

SIEGFRIED EVIONNAZ SACARISOPRODOL

DMF 52401984

UQUIFA ITALIA SPACARISOPRODOL USP

DMF 174442004

APITORIA PHARMA PRIVATE LTDCARISOPRODOL USP

DMF 193882006

HARMAN FINOCHEM LTDCARISOPRODOL USP

DMF 210642007

SOLARA ACTIVE PHARMA SCIENCES LTDCARISOPRODOL USP

DMF 231002009

CHEMECA DRUGS PRIVATE LTDCARISOPRODOL USP

DMF 351492020

WARD BLENKINSOP AND CO LTDInactiveCARISOPRODOL

DMF 51811983

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveCARISOPRODOL

DMF 174002004

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCARISOPRODOL USP (ACTIVE SUBSTANCE)

DMF 191612006

ISOCHEM SASInactiveCARISOPRODOL

DMF 194082006

FLEMING LABORATORIES LTDInactiveCARISOPRODOL USP

DMF 198012006

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveCARISOPRODOL USP

DMF 199192006

ALP PHARM BEIJING CO LTDInactiveCARISOPRODOL (DRUG SUBSTANCE, NON-STERILE)

DMF 221182008

UQUIFA MEXICO SA DE CVInactiveCARISOPRODOL

DMF 245462011

POLYDRUG LABORATORIES PVT LTDInactiveCARISOPRODOL

DMF 256872012

FLEMING LABORATORIES LTDInactiveCARISOPRODOL USP

DMF 319652017

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

Products (1)

#001 — 350MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.