Purified Cortrophin Gel
PURIFIED CORTROPHIN GEL (Repository Corticotropin Injection USP) Rx only
Approved
Approval ID
f27544ee-a0e2-4d84-b193-1c9efdf9e34c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Repository Corticotropin
PRODUCT DETAILS
NDC Product Code62559-860
Application NumberNDA008975
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateJune 21, 2023
Generic NameRepository Corticotropin
INGREDIENTS (6)
CORTICOTROPINActive
Quantity: 80 [USP'U] in 1 mL
Code: K0U68Q2TXA
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT