Estradiol
E
Approved
Approval ID
0178a92c-62b1-d5cf-cf54-2c85af88a74a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2019
Manufacturers
FDA
Alvogen Inc.
DUNS: 008057330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47781-104
Application NumberANDA209767
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estradiol
Product Specifications
Route of AdministrationVAGINAL
Effective DateMay 8, 2017
FDA Product Classification
INGREDIENTS (11)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TERT-BUTYLHYDROQUINONEInactive
Code: C12674942B
Classification: IACT
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJ
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
ESTRADIOL HEMIHYDRATEActive
Quantity: 0.1 mg in 1 g
Code: CXY7B3Q98Z
Classification: ACTIM