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GANTANOL

NDA

SULFAMETHOXAZOLE | N012715 | HOFFMANN LA ROCHE 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 Chain5 active DMFs18 inactive

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

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDSULFAMETHOXAZOLE USP

DMF 67931987

VIRCHOW LABORATORIES LTDSULFAMETHOXAZOLE USP

DMF 131851998

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDSULFAMETHOXAZOLE

DMF 252142011

EMCURE PHARMACEUTICALS LTDSULFAMETHOXAZOLE USP

DMF 263412012

EMCURE PHARMACEUTICALS LTDSULFAMETHOXAZOLE USP

DMF 356972021

SHIONOGI AND CO LTDInactiveSULFAMETHOXAZOLE N.F.

DMF 28991977

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPAInactiveSULFAMETHOXAZOLE

DMF 31441978

ACIC LTDInactiveSULFAMETHOXAZOLE

DMF 34661979

CHEMSERVICES INCInactiveSULFAMETHOXAZOLE

DMF 36391979

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveSULFAMETHOXAZOLE

DMF 42911981

ACF CHEMIEFARMA NVInactiveSULFAMETHOXAZOLE USP XX

DMF 43041981

NORTH EAST SIXTH PHARMACEUTICAL FACTORYInactiveSULFAMETHOXAZOLE USP 20

DMF 46351982

MOEHS SA DIV SANOFInactiveSULFAMETHOXAZOLE USP XX

DMF 55221984

SOL PHARMACEUTICALS LTDInactiveSULFAMETHOXAZOLE AND TRIMETHOPRIM

DMF 66741986

NAPP TECHNOLOGIES INCInactiveSULFAMETHOXAZOLE

DMF 71771987

CADILA LABORATORIES PVT LTDInactiveSULFAMETHOXAZOLE USP

DMF 73501988

SANDOZ INDIA LTDInactiveSULFAMETHOXAZOLE

DMF 78141988

EGIS PHARMACEUTICALS PRIVATE LTDInactiveSULFAMETHOXAZOLE

DMF 91441991

CHEMOX CHEMICAL INDUSTRIES LTDInactiveSULFAMETHOXAZOLE

DMF 108181994

APTE AMALGAMATIONS LTDInactiveSULFAMETHOXAZOLE

DMF 131131998

TEVA GROUPInactiveSULFAMETHOXAZOLE USP

DMF 149822000

VIBRANTIS SA DE CVInactiveSULFAMETHOXAZOLE

DMF 154142001

KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTDInactiveSULFAMETHOXAZOLE

DMF 159502002

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

Products (2)

Sort:

#002 — 500MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — 1GM

0 patents0 exclusivities▾

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