FDA.reportPublic FDA data

Application 075233

Type
ANDA
Sponsor
MYLAN TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE; TRANSDERMAL0.05MG/24HRNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLNorthwind Health Company, LLC106b92da-334c-542f-e063-6394a90aa65b2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLNorthwind Health Company, LLC0a1e744c-7926-0e0c-e063-6294a90a80d02026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLNorthwind Health Company, LLCf6caf47a-1917-c493-e053-6394a90af63e2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLNorthwind Health Company, LLCf6cb38ab-fdff-9c07-e053-6294a90ad59a2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOLESTRADIOLNorthwind Health Company, LLCf76aff99-f415-9045-e053-6294a90afd512026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.c94738ff-dece-4fb6-bb44-4f8832a45f382025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLAlvogen Inc.0178a92c-62b1-d5cf-cf54-2c85af88a74a2025-11-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLNorthStar Rx LLC1c2cd11a-e010-20b2-e063-6294a90a52d52025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLPadagis Israel Pharmaceuticals Ltdf76232ed-b109-43d1-bf2e-d41b6420c37d2025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLBryant Ranch Prepackff3bcb07-f6fe-4582-948a-21dbf1e55f552025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOL VAGINAL INSERTSESTRADIOLGlenmark Pharmaceuticals Inc., USA86620f6c-fd02-40df-98d5-3048dcd92c372025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLBryant Ranch Prepackf3806b5d-ebd6-43b4-adfa-a1fe86d806422025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.f3a77482-f490-f350-e053-2a95a90ad8cb2025-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOL VAGINAL INSERTSESTRADIOLAurobindo Pharma Limited6247e329-e20e-4ea5-9cc1-b593bd4945772025-09-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.c8ac2e13-58d5-4e70-e053-2995a90aff042025-09-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOL VAGINAL INSERTSESTRADIOLNorthStar Rx LLCad203bfd-28da-45a3-b9c0-7f886eb036342025-08-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutionse962e36d-5d84-4b39-9bdf-e5f9a264b82a2025-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutions13f9c41b-417c-45e4-9a59-baf774fca78d2025-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOL VAGINALESTRADIOLEncube Ethicals, Inc.1c61e837-4196-4b4d-9545-96b2d7c66f132025-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLMylan Pharmaceuticals Inc.e7e6da3b-8485-1382-61c9-e9b369018b982025-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30807ORIG2000-02-24
22442ORIG2000-02-24