Ovidrel
OVIDREL PreFilled Syringe(choriogonadotropin alfa injection)
Approved
Approval ID
a683e58a-63ea-44b8-a326-1a99a537bcf2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
EMD Serono, Inc.
DUNS: 088514898
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
choriogonadotropin alfa
PRODUCT DETAILS
NDC Product Code44087-1150
Application NumberBLA021149
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 26, 2023
Generic Namechoriogonadotropin alfa
INGREDIENTS (7)
CHORIOGONADOTROPIN ALFAActive
Quantity: 250 ug in 0.5 mL
Code: 6413W06WR3
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT