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PROPOFOL

ANDA

PROPOFOL | A217945 | EMERGE BIOSCIENCE PTE LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DIPRIVAN(TE code: AB)

API Supply Chain7 active DMFs6 inactive

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

CURIA ITALY SRLPROPOFOL

DMF 108681994

BACHEM SAPROPOFOL

DMF 112041994

SI GROUPPROPOFOL

DMF 117771995

EMCURE PHARMACEUTICALS LTDPROPOFOL USP

DMF 273902013

NEULAND LABORATORIES LTDPROPOFOL USP

DMF 274182013

MIDAS PHARMA GMBHPROPOFOL

DMF 410092025

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDPROPOFOL NON-STERILE DRUG SUBSTANCE

DMF 416272025

PORTON FINE CHEMICALS LTDInactivePROPOFOL USP

DMF 114061995

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactivePROPOFOL

DMF 114741995

FIS FABBRICA ITALIANA SINTETICI SPAInactivePROPOFOL

DMF 157932002

NOVADEL PHARMA INCInactivePROPOFOL LINGUAL SPRAY

DMF 178502004

UNIMARK REMEDIES LTDInactivePROPOFOL USP

DMF 237232010

HARMAN FINOCHEM LTDInactivePROPOFOL USP

DMF 290062015

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

Products (1)

#001 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 2, 2025

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

EMERGE BIOSCIENCE became the applicant for propofol (NDA 217945) in place of NANJING KING FRIEND.

Old: NANJING KING FRIEND

New: EMERGE BIOSCIENCE

MODIFIEDApplicant Full Name7/1/2026

Applicant for Propofol (NDA 217945, Supplement 001) changed from Nanjing King Friend Biochemical Pharmaceutical Co Ltd to Emerge Bioscience Pte Ltd.

Old: NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTD

New: EMERGE BIOSCIENCE PTE LTD