Estradiol

Basic Information

Product Name

Estradiol

FDA Product Code

70700-194

Regulatory Information

NDC Product Code

70700-194

Application Number

ANDA211783

Marketing Category

C73584

Effective Date

November 30, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use estradiol gel 0.1% safely and effectively. See full prescribing information for estradiol gel 0.1%. E STRADIOL GEL, for topical use Initial U.S. Approval: 1975

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Carbomer Homopolymer Type B (Allyl Pentaerythritol Or Allyl Sucrose Crosslinked)

Code: K6MOM3T5YL

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TROLAMINE

Code: 9O3K93S3TK

Class Code: IACT

ESTRADIOL

Quantity: 0.75 mg in 0.75 g

Code: 4TI98Z838E

Class Code: ACTIB

Active Moieties

Code: 4TI98Z838E

Estradiol

Basic Information

Regulatory Information

Company Information

Active Ingredients

PROPYLENE GLYCOL

Carbomer Homopolymer Type B (Allyl Pentaerythritol Or Allyl Sucrose Crosslinked)

ALCOHOL

WATER

TROLAMINE

Active Moieties

ESTRADIOL