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NDA

AMPHOTERICIN B | N050724 | LEADIANT BIOSCIENCES INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs6 inactive

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

XELLIA PHARMACEUTICALS APSAMPHOTERICIN B

DMF 136821998

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDAMPHOTERICIN B USP NON-STERILE BULK DRUG

DMF 181572005

ASENCE PHARMA PRIVATE LTDAMPHOTERICIN B USP [ORAL GRADE]

DMF 261842012

ASENCE PHARMA PRIVATE LTDAMPHOTERICIN B USP [INTENDED FOR USE IN PREPARING PARENTERAL DOSAGE FORMS]

DMF 263752012

SHANGHAI ASIA PIONEER CO LTDInactiveAMPHOTERICIN B

DMF 132241998

PFIZER INCInactiveAMPHOTERICIN B

DMF 135441998

CELL PRODUCTS INCInactiveAMPHOTERICIN B

DMF 136461998

CELL PRODUCTS INCInactiveAMPHOTERICIN B

DMF 136481998

BRISTOL MYERS SQUIBB COInactiveAMPHOTERICIN B

DMF 137011998

ASENCE PHARMA PRIVATE LTDInactiveAMPHOTERICIN B

DMF 138191998

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

Products (1)

#001 — 5MG/ML

RLD

0 patents0 exclusivities▴

INJECTABLE, LIPID COMPLEX;INJECTION | Approved: Nov 20, 1995

No patent or exclusivity listings for this strength.