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FDA Approval

Estradiol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 12, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Etonogestrel/Estradiol(0.1 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Estradiol

Product Details

NDC Product Code
50090-3645
Application Number
ANDA209767
Marketing Category
ANDA (C73584)
Route of Administration
VAGINAL
Effective Date
May 8, 2017
WATERInactive
Code: 059QF0KO0RClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
TERT-BUTYLHYDROQUINONEInactive
Code: C12674942BClass: IACT
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJClass: IACT
CERESINInactive
Code: Q1LS2UJO3AClass: IACT
Code: CXY7B3Q98ZClass: ACTIMQuantity: 0.1 mg in 1 g
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