Estradiol US FDA-Approved Products

Name Formulation Status ANDA #
Menostar, #020376 ESTRADIOL: 0.05, 0.1, 0.075, 0.025, 0.0375, 0.06, 0.014 mg/day
Extended Release Film
Prescription 020375
Estradiol, #206388 ESTRADIOL: 10 μg
Vaginal Tablet
Prescription 206388
Vivelle-Dot ESTRADIOL: 0.0375 mg/day, 0.075 mg/day, 0.05 mg/day, 0.1 mg/day Film, extended release; transdermal Discontinued ESTRADIOL: 0.0375 mg/day, 0.075 mg/day, 0.05 mg/day, 0.1 mg/day, 0.025 mg/day Film, extended release; transdermal Prescription Prescription 020538
Vivelle, #021167 ESTRADIOL: 0.0375 mg/day, 0.075 mg/day, 0.025 mg/day Film, extended release; transdermal Discontinued ESTRADIOL: 0.05 mg/day, 0.1 mg/day Film, extended release; transdermal Prescription Discontinued; Prescription 021167
Vivelle, #020323 ESTRADIOL: 0.0375 mg/day, 0.075 mg/day, 0.025 mg/day Film, extended release; transdermal Discontinued ESTRADIOL: 0.05 mg/day, 0.1 mg/day Film, extended release; transdermal Prescription Discontinued 020323
Vagifem ESTRADIOL: 25 mcg Vaginal tablet Discontinued ESTRADIOL: 10 mcg Vaginal tablet Prescription Discontinued; Prescription 020908
Prefest ESTRADIOL: 1 mg, 1 mg NORGESTIMATE: N/A, 0.09 mg Oral tablet Discontinued 021040
Minivelle ESTRADIOL: 0.0375 mg/day, 0.075 mg/day, 0.05 mg/day, 0.1 mg/day, 0.025 mg/day Film, extended release; transdermal Prescription 203752
Menostar ESTRADIOL: 0.14 mg/day Film, extended release; transdermal Prescription 021674
Innofem ESTRADIOL: 0.5 mg, 1 mg, 2 mg Oral tablet Discontinued 040312
Gynodiol ESTRADIOL: 0.5 mg, 1 mg, 1.5 mg, 2 mg Oral tablet Discontinued 040212
Femtrace ESTRADIOL ACETATE: 0.45 mg, 0.9 mg, 1.8 mg Oral tablet Discontinued 021633
Femring ESTRADIOL ACETATE: Eq. 0.05 mg base/day, Eq. 0.1 mg base/day Insert, extended release; vaginal Prescription 021367
Fempatch ESTRADIOL: 0.025 mg/day Film, extended release; transdermal Discontinued 020417
Evamist ESTRADIOL: 1.53 mg/spray Transdermal spray Prescription 022014
Estrogel ESTRADIOL: 0.06%, Topical gel Discontinued ESTRADIOL: 0.06% (1.25 g/activation) Gel, metered; transdermal Prescription Discontinued; Prescription 021166
Estring ESTRADIOL: 0.0075 mg/day Insert, extended release; vaginal Prescription 020472
Estradurin POLYESTRADIOL PHOSPHATE: 40 mg/amp Injection Discontinued 010753
Estrasorb ESTRADIOL HEMIHYDRATE: 0.25% Topical emulsion Prescription 021371
Estradiol and Norgestimate ESTRADIOL: 1 mg, 1 mg NORGESTIMATE: N/A, 0.09 mg Oral tablet Prescription 076812
Estradiol, #205256 ESTRADIOL: 10 mcg Vaginal tablet Prescription 205256
Estradiol, #201675 ESTRADIOL: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day Film, extended release; transdermal Prescription 201675
Estradiol, #075233 ESTRADIOL: 0.05 mg/day Film, extended release; transdermal Prescription 075233
Estradiol, #075182 ESTRADIOL: 0.1 mg/day, 0.075 mg/day, 0.025 mg/day, 0.0375 mg/day, 0.06 mg/day, 0.05 mg/day Film, extended release; transdermal Prescription 075182
Estradiol, #040326 ESTRADIOL: 0.5 mg, 1 mg, 2 mg Oral tablet Prescription 040326
Estradiol, #040297 ESTRADIOL: 0.5 mg, 1 mg, 2 mg Oral tablet Discontinued 040297
Estradiol, #040275 ESTRADIOL: 0.5 mg, 1 mg, 2 mg Oral tablet Prescription 040275
Estradiol, #040197 ESTRADIOL: 0.5 mg, 1 mg, 2 mg Oral tablet Prescription 040197
Estradiol, #040138 ESTRADIOL: 0.5 mg, 1 mg, 2 mg Oral tablet Discontinued 040138
Estradiol, #040114 ESTRADIOL: 1 mg, 2 mg, 0.5 mg Oral tablet Prescription 040114
Estradiol, #021048 ESTRADIOL: 0.05 mg/day, 0.075 mg/day, 0.1 mg/day Film, extended release; transdermal Discontinued 021048
Estradiol, #020538 ESTRADIOL: 0.0375 mg/day, 0.075 mg/day, 0.05 mg/day, 0.1 mg/day Film, extended release; transdermal Discontinued 020538
Estraderm ESTRADIOL: 0.05 mg/day, 0.1 mg/day Film, extended release; transdermal Discontinued 019081
Estrace, #086069 ESTRADIOL: 0.01% Vaginal cream Prescription 086069
Estrace, #084500 2 mg Oral tablet Discontinued 084500
Estrace, #084499 1 mg Oral tablet Discontinued 084499
Estrace, #081295 0.5 mg Oral tablet Discontinued 081295
Esclim ESTRADIOL: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day Film, extended release; transdermal Discontinued 020847
Elestrin ESTRADIOL: 0.06% (0.87 mg/activation) Transdermal gel, metered Prescription 021813
Divigel ESTRADIOL: 0.1% (0.25 g/packet), 0.1% (0.5 g/packet), 0.1% (1 g/packet) Transdermal gel Prescription 022038
Climara ESTRADIOL: 0.05 mg/day, 0.1 mg/day, 0.075 mg/day, 0.025 mg/day, 0.0375 mg/day, 0.06 mg/day Film, extended release; transdermal Prescription 020375
Alora, #021310 ESTRADIOL Film, extended release; transdermal Prescription 021310
Alora, #020655 ESTRADIOL: 0.05 mg/day, 0.075 mg/day, 0.1 mg/day, 0.025 mg/day Film, extended release; transdermal Prescription 020655
Estradiol and Norethindrone Acetate, #207261 ESTRADIOL: 0.5 mg, 1 mg
NORETHINDRONE ACETATE: 0.1 mg, 0.5 mg
Oral tablet
Prescription 207261
Estradiol and Norethindrone Acetate, #200747 ESTRADIOL: 0.5 mg
NORETHINDRONE ACETATE: 0.1 mg
Oral tablet
Prescription 200747
Estradiol and Norethindrone Acetate, #079193 ESTRADIOL: 1 mg
NORETHINDRONE ACETATE: 0.5 mg
Oral tablet
Prescription 079193
Estradiol and Norethindrone Acetate, #078324 ESTRADIOL: 1 mg, 0.5 mg
NORETHINDRONE ACETATE: 0.5 mg, 0.1 mg
Oral tablet
Prescription 078324
Combipatch ESTRADIOL: 0.05 mg/24 h, 0.05 mg/24 h
NORETHINDRONE ACETATE: 0.14 mg/24 h, 0.25 mg/24h
Transdermal patch
Prescription 020870
Amabelz ESTRADIOL: 0.5 mg, 1 mg
NORETHINDRONE ACETATE: 0.1 mg, 0.5 mg
Oral tablet
Prescription 203339
Activella (Novo Nordisk) ESTRADIOL: 1 mg
NORETHINDRONE ACETATE: 0.5 mg
Oral tablet
Prescription 021103, 022001
Activella (Amneal Pharms) ESTRADIOL: 1 mg, 0.5 mg
NORETHINDRONE ACETATE: 0.5 mg, 0.1 mg
Oral tablet
Prescription 020907
Angeliq DROSPIRENONE: 0.25 mg, 0.5 mg ESTRADIOL: 0.5 mg, 1 mg Oral tablet Prescription 021355
Climara Pro ESTRADIOL: 0.045 mg/day LEVONORGESTREL 0.015 mg/day Film, Extended Release, Transdermal; Apply once-weekly to lower abdomen Each 22 cm^2 system contains 4.4 mg estradiol and 1.39 mg levonorgestrel. System comprises three layers: (1) a translucent polyethylene backing film (2) an acrylate adhesive matrix containing estradiol and levonorgestrel (acrylate copolymer adhesive and polyvinylpyrrolidone/vinylacetate copolymer) (3) A protective layer of either siliconized or fluoropolymer coated polyester film. The protective liner is attached to the adhesive surface and must be removed before the system can be used. Prescription 021258 (Bayer), 021885 (Berlex)