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NDA

WARFARIN SODIUM | N011771 | PHARMACEUTICAL RESEARCH ASSOC INC

7 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 Chain12 active DMFs8 inactive

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

APOTEX INCWARFARIN SODIUM CLATHRATE USP

DMF 113871995

TAPI NL BVWARFARIN SODIUM CLATHRATE

DMF 122691996

TARO PHARMACEUTICAL INDUSTRIES LTDWARFARIN SODIUM CLATHRATE USP

DMF 127461997

ZYDUS LIFESCIENCES LTDWARFARIN SODIUM USP (CRYSTALLINE CLATHRATE)

DMF 129771998

IPCA LABORATORIES LTDWARFARIN SODIUM CLATHRATE USP

DMF 216802008

CHIERON ACTIVE INGREDIENTS PRIVATE LTDWARFARIN SODIUM USP (AMORPHOUS)

DMF 219252008

FARMAK ASWARFARIN SODIUM

DMF 221322008

ALCHYMARS ICM SM PRIVATE LTDWARFARIN SODIUM USP

DMF 222992008

RAKS PHARMA PVT LTDWARFARIN SODIUM CLATHRATE USP

DMF 232892009

ALEMBIC PHARMACEUTICALS LTDWARFARIN SODIUM AMORPHOUS USP

DMF 247122011

ALEMBIC PHARMACEUTICALS LTDWARFARIN SODIUM CLATHRATE USP

DMF 247962011

CHIERON ACTIVE INGREDIENTS PRIVATE LTDWARFARIN SODIUM CLATHRATE

DMF 364062021

BRISTOL MYERS SQUIBB COInactiveWARFARIN SODIUM USP

DMF 24671975

MEDEA RESEARCH LABORATORIES INCInactiveWARFARIN SODIUM

DMF 105301993

NAPP TECHNOLOGIES INCInactiveWARFARIN SODIUM CLATHRATE

DMF 121171996

ASPEN OSS BVInactiveWARFARIN SODIUM

DMF 143991999

NUTRA SPECIALITIES PRIVATE LTDInactiveWARFARIN SODIUM USP (CLATHRATE)

DMF 219262008

IPCA LABORATORIES LTDInactiveWARFARIN SODIUM USP

DMF 222152009

QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTDInactiveWARFARIN SODIUM (NON-STERILE, API)

DMF 262682012

UNICHEM LABORATORIES LTDInactiveWARFARIN SODIUM USP

DMF 289252014

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