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 7 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YUVAFEMESTRADIOLAmneal Pharmaceuticals LLC30c7f6ba-7a9e-4853-b3e4-e00a465602242024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLAmneal Pharmaceuticals of New York LLC094830ee-1b1c-4cf7-8a39-427dfd56f9c92024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.8cb31c7c-fba8-4201-833d-844ea1a8a4de2024-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
estradiolESTRADIOLZydus Pharmaceuticals USA Inc.684850eb-d889-4370-a0a7-4a5c3113266a2024-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: estradiol
generic name: ESTRADIOL
estradiolESTRADIOLZydus Pharmaceuticals USA Inc.db4696da-7820-4b2b-97b4-fb05b12080202024-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLZydus Pharmaceuticals USA Inc.839fe7ae-6835-4d6a-b6b1-ca7f062caa4f2024-03-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLSandoz Incc4da6de7-9ab1-4fcf-88f3-fe785019e6e72024-02-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.c4936878-1643-4e7f-9b0d-e4957935aef22024-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ELESTRINESTRADIOLViatris Specialty LLCeff2dea1-f117-11e3-ac10-0800200c9a662023-12-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutions31646359-292c-4bca-88a4-7a89b11c3f442023-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
Vivelle-DotESTRADIOLSandoz Inc5ccb77f9-d47b-4381-ad5c-5b92524e1c4a2023-11-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estrogen 4XESTRADIOLNutritional Specialties, Inc.772c2a8a-10e2-49af-8db6-4d5ca64b17192023-07-25WarningsName fallback
generic name: ESTRADIOL
estradiolESTRADIOLZydus Lifesciences Limited2f2030c2-f72e-4142-9cff-540bc8fbf8a12023-04-21Name fallback
brand name: estradiol
generic name: ESTRADIOL
estradiolESTRADIOLZydus Lifesciences Limited8b672c79-0896-4d6e-b225-299e89068ad72023-04-21Name fallback
brand name: estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLZydus Lifesciences Limitedb79fd5ea-962f-491c-b670-40efe42ccf792022-12-07Name fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOLESTRADIOLAsclemed USA, Inc.229b4ec5-d3c8-4406-9fc5-8f633c6447b82022-10-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
EstradiolESTRADIOLPharmPak, Inc.8f8c5a0b-4d7b-a5cb-e053-2995a90a494e2022-10-09Boxed 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