Estra-50
Estra-50 & Estra-25
Approved
Approval ID
596a20bd-d93d-4c48-e053-2991aa0ad4ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2024
Manufacturers
FDA
Advanced Pharmaceutical Technology, Inc.
DUNS: 023237884
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
estradiol pellet
PRODUCT DETAILS
NDC Product Code57377-025
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 13, 2024
Generic Nameestradiol pellet
INGREDIENTS (3)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ESTRADIOLActive
Quantity: 25 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
Estradiol pellet
PRODUCT DETAILS
NDC Product Code57377-050
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 13, 2024
Generic NameEstradiol pellet
INGREDIENTS (3)
ESTRADIOLActive
Quantity: 50 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT