Viewing data from:

PROLOPRIM

NDA

TRIMETHOPRIM | N017943 | MONARCH PHARMACEUTICALS INC

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 Chain9 active DMFs23 inactive

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

TAPI NL BVTRIMETHOPRIM USP

DMF 28721977

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDTRIMETHOPRIM USP

DMF 67951987

IPCA LABORATORIES LTDTRIMETHOPRIM USP

DMF 85451990

SHANDONG XINHUA PHARMACEUTICAL CO LTDTRIMETHOPRIM USP

DMF 131441998

INVENTAA INDUSTRIES PRIVATE LTDTRIMETHOPRIM USP

DMF 155062001

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDTRIMETHOPRIM

DMF 251952011

IPCA LABORATORIES LTDTRIMETHOPRIM USP

DMF 256622012

SHANDONG RONGYUAN PHARMACEUTICAL CO LTDTRIMETHOPRIM

DMF 278802014

ANDHRA ORGANICS LTDTRIMETHOPRIM USP

DMF 329932018

ISTITUTO CHEMICOTHERAPICO ITALIANOInactiveTRIMETHOPRIM BULK, BP 1973

DMF 31471978

ACIC LTDInactiveTRIMETHOPRIM

DMF 34681979

DINAMITE DIPHARMA SPAInactiveTRIMETHOPRIM BP 73

DMF 35021978

FABBRICA ITALIANA SINTETICI SPAInactiveTRIMETHOPRIM USP, BULK FORM

DMF 42051981

SIGMA F AND D DIV LTDInactiveTRIMETHOPRIM

DMF 47261982

LUDWIG HEUMANN AND CO GMBHInactiveTRIMETHOPRIM

DMF 47551983

MEDIMPEX NORTH AMERICA INCInactiveTRIMETHOPRIM

DMF 48761983

NORTH EAST SIXTH PHARMACEUTICAL FACTORYInactiveTRIMETHOPRIM USP BULK

DMF 57811985

JAGSONPAL PHARMACEUTICALS PRIVATE LTDInactiveTRIMETHOPRIM

DMF 57861985

NAPP CHEMICALS INCInactiveTRIMETHOPRIM USP

DMF 58151985

DAEWOONG CHEMICAL CO LTDInactiveTRIMETHOPRIM

DMF 60171985

FABBRICA ITALIANA SINTETICI SPAInactiveTRIMETHOPRIM AF (ANILINE FREE)

DMF 62231985

MOEHS SA DIV SANOFInactiveTRIMETHOPRIM

DMF 68801987

CADILA LABORATORIES PVT LTDInactiveTRIMETHOPRIM

DMF 71951987

GUANGDONG PHARMACEUTICAL FACTORYInactiveTRIMETHOPRIM AND SULFAMETHOXAZOLE

DMF 72771988

BOMBAY DRUG HOUSE LTDInactiveTRIMETHOPRIM

DMF 76771988

OREX PHARMA PVT LTDInactiveTRIMETHOPRIM

DMF 78751989

BURROUGHS WELLCOME INDIA LTDInactiveTRIMETHOPRIM BULK DRUG PRODUCT

DMF 92401991

STANDARD ORGANICS LTDInactiveTRIMETHOPRIM USP (NON-STERILE BULK)

DMF 119341996

WYCKOFF CHEMICAL CO INCInactiveTRIMETHOPRIM

DMF 127341997

HALCYON LABS PRIVATE LTDInactiveTRIMETHOPRIM USP

DMF 128161998

SIFAVITOR SRLInactiveTRIMETHOPRIM

DMF 155102001

ALPHA DRUG INDIA LTDInactiveTRIMETHOPRIM

DMF 159842002

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 20, 2006	SUPPL -17	View Letter (PDF)
Aug 26, 2002	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 14, 1982