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AMPHOTERICIN B

ANDA

AMPHOTERICIN B | A212514 | SUN PHARMA INDUSTRIES LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: AMBISOME(TE code: AB)

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 12, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/VIAL

0 patents0 exclusivities▴

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Dec 14, 2021

No patent or exclusivity listings for this strength.