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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57377-025
Product Classification
G
Generic Name
estradiol pellet
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 13, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57377-050
Product Classification
G
Generic Name
Estradiol pellet
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 13, 2024
FDA Product Classification
INGREDIENTS (3)
ESTRADIOLActive
Quantity: 50 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT