Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
HF Acquisition Co LLC, DBA HealthFirst
045657305
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
045657305
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROPOFOL
Product Details
NDC Product Code
51662-1471Application Number
ANDA077908Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
February 23, 2020SOYBEAN OILInactive
Code: 241ATL177AClass: IACTQuantity: 100 mg in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACTQuantity: 22.5 mg in 1 mL
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACTQuantity: 0.7 mg in 1 mL
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGVClass: IACTQuantity: 12 mg in 1 mL
PropofolActive
Code: YI7VU623SFClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 1.5 mg in 1 mL