FDA.reportPublic FDA data

Application 021167

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIVELLEESTRADIOLFILM, EXTENDED RELEASE; TRANSDERMAL0.0375MG/24HRNoNo
002VIVELLEESTRADIOLFILM, EXTENDED RELEASE; TRANSDERMAL0.05MG/24HRNoNo
003VIVELLEESTRADIOLFILM, EXTENDED RELEASE; TRANSDERMAL0.075MG/24HRNoNo
004VIVELLEESTRADIOLFILM, EXTENDED RELEASE; TRANSDERMAL0.1MG/24HRNoNo
005VIVELLEESTRADIOLFILM, EXTENDED RELEASE; TRANSDERMAL0.025MG/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 5 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESTRADIOLESTRADIOLA-S Medication Solutions376beb31-5fed-4aae-a16f-71a7d243d5eb2025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLA-S Medication Solutionse5dbfeff-188f-4991-b2b7-f5f03987f7fb2025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLPURACAP LABORATORIES, LLC97ace322-341a-4d52-8c63-17265ed9aa8d2025-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLEPIC PHARMA, LLC9333d92f-2585-4b99-aaea-87c01c95125e2025-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutionsf7e8dd35-c12f-46be-96f9-bf9a9b6f9a902024-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutions41f424ec-9d08-4fda-b21d-41e92da6e1f02024-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EvamistESTRADIOLPadagis US LLC9a0aa631-133d-406b-9d32-8a1a99af4e502024-10-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3518120e-cc44-4d70-8a20-0ef2dce9a3c62024-10-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLProficient Rx LP7e570b07-2a9e-49bf-b224-1e34f6eda3ab2024-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.230c2eda-b0f1-d9ec-e063-6394a90a603c2024-09-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLBryant Ranch Prepack5e9bd73f-67db-44f9-a5ee-409eed765cd22024-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLBryant Ranch Prepack74baff07-15df-48a8-93b8-3a317f896a562024-08-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
DOTTIESTRADIOLBryant Ranch Prepack75fc6d3a-49b6-47ad-b704-410692010d3a2024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
DOTTIESTRADIOLBryant Ranch Prepackb119df4a-c514-4804-b1a8-b09c6058e80d2024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
DOTTIESTRADIOLBryant Ranch Prepackf419192a-eb95-4087-9fe0-0eea639ef51b2024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRACEESTRADIOLA-S Medication Solutionsda52a602-f2a2-4382-be07-30351c58cc4b2024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
DOTTIESTRADIOLBryant Ranch Prepack779751dc-243a-4dc2-ae67-3669f196b2052024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLBryant Ranch Prepacke7b15ec3-e195-44a6-bdd7-9b6de2b235b82024-07-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutions7f3c96ce-c855-4372-95ba-7759dd82bcca2024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.5423c0da-eb10-20cd-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
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
21484ORIG2004-04-13
26957ORIG2000-08-16
14546ORIG2000-08-16