ESTRADIOL - Food and Drug Administration

Set ID
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6
Type
Indexing - product concept
Effective date
2025-06-16
Version
2
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
Estradiol Tablets, USPProduct nameREMEDYREPACK INC.2026-10-08
These highlights do not include all the information needed to use BIJUVA safely and effectively. See full prescribing information for BIJUVA. BIJUVA ® (estradiol and progesterone) capsules, for oral use Initial U.S. Approval: 2018Product nameMayne Pharma | Catalent Pharma Solutions, LLC | Sharp Packaging Services, LLC2026-09-29
These highlights do not include all the information needed to use BIJUVA safely and effectively. See full prescribing information for BIJUVA. BIJUVA ® (estradiol and progesterone) capsules, for oral use Initial U.S. Approval: 2018Product nameMayne Pharma LLC | Catalent Pharma Solutions, LLC2026-09-29
These highlights do not include all the information needed to use IMVEXXY safely and effectively. See full prescribing information for IMVEXXY. IMVEXXY ® (estradiol vaginal inserts) Initial U.S. Approval: 1975Product nameMayne Pharma | Catalent Pharma Solutions, LLC | Sharp Packaging Services, LLC2026-09-29
Estradiol Vaginal Cream USP 0.01%Product nameA-S Medication Solutions2026-08-28
DRUG FACTS:Product nameBioActive Nutritional, Inc. | Apotheca Company2026-08-24
These highlights do not include all the information needed to use Estradiol Gel safely and effectively. See full prescribing information for Estradiol Gel. Estradiol Gel, for topical use Initial U.S. Approval: 1975Product nameTrigen Laboratories, LLC2026-08-21
These highlights do not include all the information needed to use MINIVELLE safely and effectively. See full prescribing information for MINIVELLE. MINIVELLE ® (estradiol transdermal system) Initial U.S. Approval: 1975Product nameNoven Therapeutics, LLC | Noven Pharmaceuticals, Inc.2026-07-31
ESTRADIOL VALERATE INJECTION, USP Rx OnlyProduct nameXiromed, LLC | Xiromed Pharma Espana, S.L. | Laboratorios Farmalan, S.A. (Chemo)2026-07-06
Estradiol Tablets, USPProduct nameA-S Medication Solutions2026-07-01
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameANI Pharmaceuticals, Inc. | Novitium Pharma LLC2026-06-23
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameBryant Ranch Prepack2026-06-16
Synovex ® CProduct nameZoetis Inc.2026-06-12
SYNOVEX ® ONE GROWERProduct nameZoetis Inc.2026-06-12
Estradiol Tablets, USP Rx onlyProduct nameREMEDYREPACK INC.2026-06-10
Estradiol Tablets, USP Rx onlyProduct nameREMEDYREPACK INC.2026-06-10
Estradiol Tablets, USPProduct nameREMEDYREPACK INC.2026-06-08
Estradiol Tablets, USPProduct nameREMEDYREPACK INC.2026-06-01
These highlights do not include all the information needed to use ESTRADIOL AND NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL AND NORETHINDRONE ACETATE TABLETS. ESTRADIOL and NORETHINDRONE ACETATE tablets, for oral use Initial U.S. Approval: 1998Product nameIngenus Pharmaceuticals, LLC | Novast Laboratories, Ltd.2026-05-29
These highlights do not include all the information needed to use ESTROGEL safely and effectively. See full prescribing information for ESTROGEL. EstroGel ® 0.06% (estradiol gel) for topical use Initial U.S. Approval: 1975Product nameASCEND Therapeutics US, LLC | DPT Laboratories, Ltd.2026-05-29
Estradiol Tablets, USPProduct nameA-S Medication Solutions2026-05-27
Estradiol Tablets, USPProduct nameREMEDYREPACK INC.2026-05-26
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: 1975Product nameXiromed, LLC | Chemo Research, S.L. | Laboratorios Leon Farma2026-05-18
DELESTROGEN ® (estradiol valerate injection, USP)Product namePar Health USA, LLC2026-05-13
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameEncube Ethicals, Inc. | Encube Ethicals Private Limited2026-05-13
DELESTROGEN ® (estradiol valerate injection, USP)Product namePar Health USA, LLC2026-05-06
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameEncube Ethicals, Inc. | Encube Ethicals Private Limited2026-04-29
Revalor ® -XH (trenbolone acetate and estradiol extended-release implants)Product nameMerck Sharp & Dohme Corp. | Intervet GesmbH2026-04-27
These highlights do not include all the information needed to use BIJUVA safely and effectively. See full prescribing information for BIJUVA. BIJUVA ® (estradiol and progesterone) capsules, for oral use Initial U.S. Approval: 2018Product nameMayne Pharma | Catalent Pharma Solutions, LLC | Sharp Packaging Services, LLC2026-04-24
ESTRING ® (estradiol vaginal system)Product namePfizer Laboratories Div Pfizer Inc | Pfizer Inc2026-04-23
These highlights do not include all the information needed to use BIJUVA safely and effectively. See full prescribing information for BIJUVA. BIJUVA ® (estradiol and progesterone) capsules, for oral use Initial U.S. Approval: 2018Product nameMayne Pharma LLC | Catalent Pharma Solutions LLC2026-04-16
Estradiol Tablets, USP Rx onlyProduct namePreferred Pharmaceuticals, Inc.2026-04-13
ESTRADIOL VAGINAL CREAM USP, 0.01%Product nameA-S Medication Solutions2026-04-13
SYNOVEX ® ONE FEEDLOTProduct nameZoetis Inc.2026-04-06
ESTRADIOL VAGINAL CREAM USP, 0.01%Product nameBryant Ranch Prepack2026-03-31
These highlights do not include all the information needed to use CLIMARA PRO safely and effectively. See full prescribing information for CLIMARA PRO. Climara Pro ® (estradiol/levonorgestrel transdermal system) Initial U.S. Approval: 1975Product nameBayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLC2026-03-26
These highlights do not include all the information needed to use CLIMARA safely and effectively. See full prescribing information for CLIMARA. Climara® (estradiol transdermal system) Initial U.S. Approval: 1975Product nameBayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLC2026-03-26
These highlights do not include all the information needed to use MENOSTAR safely and effectively. See full prescribing information for MENOSTAR. Menostar ® (estradiol transdermal system) Initial U.S. Approval: 1975Product nameBayer HealthCare Pharmaceuticals Inc.2026-03-12
These highlights do not include all the information needed to use the ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for ESTRADIOL TRANSDERMAL SYSTEM. Estradiol Transdermal System Initial U.S. Approval: 1975Product nameSandoz Inc | Bayer HealthCare Pharmaceuticals Inc.2026-03-04
These highlights do not include all the information needed to use ANGELIQ safely and effectively. See full prescribing information for ANGELIQ. ANGELIQ (drospirenone and estradiol) tablets, for oral use Initial U.S. Approval: 2005Product nameBayer HealthCare Pharmaceuticals Inc.2026-03-02
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product namePadagis Israel Pharmaceuticals Ltd2026-02-28
These highlights do not include all the information needed to use DIVIGEL safely and effectively. See full prescribing information for DIVIGEL. DIVIGEL ® (estradiol gel), for topical use Initial U.S. Approval: 1975Product nameVertical Pharmaceuticals, LLC2026-02-27
These highlights do not include all the information needed to use Estradiol Gel safely and effectively. See full prescribing information for Estradiol Gel. Estradiol Gel, for topical use Initial U.S. Approval: 1975Product nameTrigen Laboratories, LLC2026-02-27
Estradiol Tablets, USPProduct nameEPIC PHARMA, LLC | GRANULATION TECHNOLOGY, INC.2026-02-26
ESTRING ® (estradiol vaginal system)Product namePfizer Laboratories Div Pfizer Inc | Pfizer Inc2026-02-26
These highlights do not include all the information needed to use BIJUVA safely and effectively. See full prescribing information for BIJUVA. BIJUVA ® (estradiol and progesterone) capsules, for oral use Initial U.S. Approval: 2018Product nameMayne Pharma LLC | Catalent Pharma Solutions LLC2026-02-25
DRUG FACTS:Product nameDeseret Biologicals, Inc. | Apotheca Company2026-02-19
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC2026-02-19
These highlights do not include all the information needed to use BIJUVA safely and effectively. See full prescribing information for BIJUVA. BIJUVA ® (estradiol and progesterone) capsules, for oral use Initial U.S. Approval: 2018Product nameMayne Pharma | Catalent Pharma Solutions, LLC | Sharp Packaging Services, LLC2026-02-17
Mylan Pharmaceuticals Inc. human prescription drug labelProduct nameMylan Pharmaceuticals Inc.2026-02-15
Estradiol Tablets, USPProduct nameREMEDYREPACK INC.2026-02-13
These highlights do not include all the information needed to use ESTRADIOL GEL 0.1% safely and effectively. See full prescribing information for ESTRADIOL GEL0.1%. E STRADIOL GEL, for topical use Initial U.S. Approval: 1975Product nameXiromed, LLC | Chemo Research, S.L. | Laboratorios Leon Farma2026-02-12
These highlights do not include all the information needed to use ESTROGEL safely and effectively. See full prescribing information for ESTROGEL. EstroGel ® 0.06% (estradiol gel) for topical use Initial U.S. Approval: 1975Product nameASCEND Therapeutics US, LLC | DPT Laboratories, Ltd.2026-01-27
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameSolaris Pharma Corporation2026-01-26
These highlights do not include all the information needed to use ESTROGEL safely and effectively. See full prescribing information for ESTROGEL. EstroGel ® 0.06% (estradiol gel) for topical use Initial U.S. Approval: 1975Product nameASCEND Therapeutics US, LLC | DPT Laboratories, Ltd.2026-01-21
Yuvafem These highlights do not include all the information needed to use YUVAFEM safely and effectively. See full prescribing information for YUVAFEM. YUVAFEM® (estradiol vaginal inserts) Initial U.S. Approval: 1999Product nameAvKARE2026-01-19
Estradiol Vaginal Cream USP, 0.01%Product nameAvKARE2026-01-14
EstradiolProduct nameDirect_Rx2026-01-08
R317Product nameProfessional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC2026-01-08
YESDProduct nameProfessional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC2026-01-08
Estradiol Tablets, USPProduct nameNorthwind Health Company, LLC2026-01-01
Estradiol Tablets, USPProduct nameNorthwind Health Company, LLC2026-01-01
Estradiol Tablets, USPProduct nameNorthwind Health Company, LLC2026-01-01
Estradiol Tablets, USP Rx onlyProduct nameNorthwind Health Company, LLC2026-01-01
Estradiol Tablets, USP Rx onlyProduct nameNorthwind Health Company, LLC2026-01-01
DELESTROGEN ® (estradiol valerate injection, USP)Product namePar Health USA, LLC2025-12-26
EstroPRO Homeopathic OrganotherapyProduct nameProBlen2025-12-22
These highlights do not include all the information needed to use ORIAHNN safely and effectively. See full prescribing information for ORIAHNN. ORIAHNN ® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), co-packaged for oral use Initial U.S. Approval: 2020Product nameAbbVie Inc.2025-12-19
DRUG FACTS:Product nameDeseret Biologicals | Apotheca Company2025-12-11
These highlights do not include all the information needed to use FEMRING safely and effectively. See Full Prescribing Information for FEMRING. Femring ® (estradiol acetate vaginal ring) Initial U.S. Approval: 1975Product nameMillicent US, Inc. | Millicent Pharma (NI) Limited2025-12-09
These highlights do not include all the information needed to use ESTRADIOL AND NORETHINDRONE ACETATE TABLETS safely and effectively. See full prescribing information for ESTRADIOL AND NORETHINDRONE ACETATE TABLETS. ESTRADIOL and NORETHINDRONE ACETATE tablets, for oral use Initial U.S. Approval: 1998Product nameIngenus Pharmaceuticals, LLC | Novast Laboratories, Ltd.2025-12-05
006 ESTRIOL CREAMProduct nameShenzhen Mengyue Technology Co., Ltd.2025-12-01
Estradiol Vaginal Cream USP 0.01%Product nameTeva Pharmaceuticals USA, Inc.2025-12-01
E stradiol Vaginal Cream , USP 0.01%Product nameAlvogen Inc.2025-11-25
Elanco US Inc. prescription animal drug labelProduct nameElanco US Inc.2025-11-21
Elanco US Inc. prescription animal drug labelProduct nameElanco US Inc.2025-11-21
Elanco US Inc. prescription animal drug labelProduct nameElanco US Inc.2025-11-21
Elanco US Inc. prescription animal drug labelProduct nameElanco US Inc.2025-11-21
Elanco US Inc. prescription animal drug labelProduct nameElanco US Inc.2025-11-21
DRUG FACTS:Product nameNutritional Specialties, Inc.2025-11-19
84735-014 Estriol creamProduct nameHengyang Chuangjiujia Trading Co., Ltd.2025-11-12
Estradiol Tablets, USP Rx onlyProduct nameNorthStar Rx LLC | ANI Pharmaceuticals, Inc.2025-11-11
ESTRADIOL VALERATE INJECTION, USP RX ONLYProduct nameHikma Pharmaceuticals USA Inc.2025-11-10
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameANI Pharmaceuticals, Inc. | Novitium Pharma LLC2025-11-04
ESTRADIOL VAGINAL CREAM USP, 0.01%Product namePadagis Israel Pharmaceuticals Ltd2025-10-31
Elanco US Inc. otc animal drug labelProduct nameElanco US Inc.2025-10-28
Elanco US Inc. otc animal drug labelProduct nameElanco US Inc.2025-10-28
Estradiol Tablets, USP Rx onlyProduct nameBryant Ranch Prepack2025-10-28
These highlights do not include all the information needed to use ESTRADIOL VAGINAL INSERTS safely and effectively. See full prescribing information for ESTRADIOL VAGINAL INSERTS. ESTRADIOL vaginal inserts Initial U.S. Approval: 1999Product nameGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2025-10-28
ESTRADIOL VAGINAL CREAM USP, 0.01%Product nameBryant Ranch Prepack2025-10-23
Estradiol Tablets, USPProduct namePD-Rx Pharmaceuticals, Inc.2025-10-09
Revalor ® -200 (trenbolone acetate and estradiol implants)Product nameMerck Sharp & Dohme Corp. | Intervet GesmbH2025-09-29
Revalor ® -H (trenbolone acetate and estradiol implants)Product nameMerck Sharp & Dohme Corp. | Intervet GesmbH2025-09-29
Revalor ® -IH (trenbolone acetate and estradiol implants)Product nameMerck Sharp & Dohme Corp. | Intervet GesmbH2025-09-29
These highlights do not include all the information needed to use ESTRADIOL VAGINAL INSERTS safely and effectively. See full prescribing information for ESTRADIOL VAGINAL INSERTS. ESTRADIOL vaginal inserts Initial U.S. Approval: 1999Product nameAurobindo Pharma Limited2025-09-23
Estradiol Tablets USPProduct nameNuCare Pharmaceuticals,Inc.2025-09-22
These highlights do not include all the information needed to use IMVEXXY safely and effectively. See full prescribing information for IMVEXXY. IMVEXXY ® (estradiol vaginal inserts) Initial U.S. Approval: 1975Product nameMayne Pharma LLC | Catalent Pharma Solutions LLC2025-09-16
These highlights do not include all the information needed to use MYFEMBREE safely and effectively. See full prescribing information for MYFEMBREE. MYFEMBREE ® (relugolix, estradiol, and norethindrone acetate) tablets, for oral use Initial U.S. Approval: 2021Product nameSumitomo Pharma America, Inc | Sumitomo Pharma Switzerland GmbH2025-09-04
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product namePadagis Israel Pharmaceuticals Ltd2025-08-31
Revalor ® -IS (trenbolone acetate and estradiol implants)Product nameMerck Sharp & Dohme Corp.2025-08-15
Revalor ® -S (trenbolone acetate and estradiol implants)Product nameMerck Sharp & Dohme Corp.2025-08-15
Revalor ® -XS (trenbolone acetate and estradiol extended-release implants)Product nameMerck Sharp & Dohme Corp. | Intervet GesmbH2025-08-15
Revalor ® -GProduct nameMerck Sharp & Dohme Corp.2025-08-13
These highlights do not include all the information needed to use ESTRADIOL VAGINAL INSERTS safely and effectively. See full prescribing information for ESTRADIOL VAGINAL INSERTS. ESTRADIOL vaginal inserts Initial U.S. Approval: 1999Product nameNorthStar Rx LLC | Aurobindo Pharma Limited2025-08-08
Estradiol Tablets, USP Rx onlyProduct nameREMEDYREPACK INC.2025-08-05
Estradiol Tablets, USP Rx onlyProduct nameREMEDYREPACK INC.2025-08-05
84735-014 Estriol creamProduct nameHengyang Chuangjiujia Trading Co., Ltd.2025-07-28
These highlights do not include all the information needed to use ESTRADIOL TRANSDERMAL SYSTEM CONTINUOUS DELIVERY (ONCE-WEEKLY) safely and effectively. See full prescribing information for ESTRADIOL TRANSDERMAL SYSTEM CONTINUOUS DELIVERY (ONCE-WEEKLY). ESTRADIOL transdermal system continuous delivery (once-weekly) Initial U.S. Approval: 1975Product nameA-S Medication Solutions2025-07-24
These highlights do not include all the information needed to use ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for ESTRADIOL TRANSDERMAL SYSTEM ESTRADIOL TRANSDERMAL SYSTEM Initial U.S. Approval: 1975Product nameA-S Medication Solutions2025-07-24
Estradiol Vaginal Cream, USP 0.01%Product nameEncube Ethicals, Inc. | Encube Ethicals Private Limited2025-07-17
Estradiol BenzoateProduct nameAX Pharmaceutical Corp2025-07-15
Nutrition Unlimited INC human otc drug labelProduct nameNutrition Unlimited INC2025-07-05
ESTRADIOL VALERATE INJECTION, USP Rx OnlyProduct nameXiromed, LLC | Xiromed Pharma Espana, S.L. | Laboratorios Farmalan, S.A. (Chemo)2025-07-03
These highlights do not include all the information needed to use ESTRADIOL TRANSDERMAL SYSTEM (TWICE-WEEKLY) safely and effectively. See full prescribing information for ESTRADIOL TRANSDERMAL SYSTEM (TWICE-WEEKLY). ESTRADIOL transdermal system (twice-weekly) Initial U.S. Approval: 1975Product nameMylan Pharmaceuticals Inc.2025-06-23
These highlights do not include all the information needed to use ESTRADIOL TRANSDERMAL SYSTEM CONTINUOUS DELIVERY (ONCE-WEEKLY) safely and effectively. See full prescribing information for ESTRADIOL TRANSDERMAL SYSTEM CONTINUOUS DELIVERY (ONCE-WEEKLY). ESTRADIOL transdermal system continuous delivery (once-weekly) Initial U.S. Approval: 1975Product nameMylan Pharmaceuticals Inc.2025-06-23
Estradiol Tablets, USP Rx onlyProduct nameCoupler LLC2025-06-17
These highlights do not include all the information needed to use ESTRADIOL TRANSDERMAL SYSTEM (TWICE-WEEKLY) safely and effectively. See full prescribing information for ESTRADIOL TRANSDERMAL SYSTEM (TWICE-WEEKLY). ESTRADIOL transdermal system (twice-weekly) Initial U.S. Approval: 1996Product nameMylan Pharmaceuticals Inc.2025-06-17
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameNorthStar Rx LLC2025-06-16
These highlights do not include all the information needed to use ESTRADIOL GEL safely and effectively. See full prescribing information for ESTRADIOL GEL. ESTRADIOL gel, for topical use Initial U.S. Approval: 1975Product nameANI Pharmaceuticals, Inc. | Novitium Pharma LLC2025-06-10
Estradiol Tablets, USPProduct nameREMEDYREPACK INC.2025-06-02