FDA.reportPublic FDA data

Application 214137

Type
ANDA
Sponsor
TEVA PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLINSERT;VAGINAL0.004MGNoNo
002ESTRADIOLESTRADIOLINSERT;VAGINAL0.01MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214137-001ESTRADIOLESTRADIOL0.004MGINSERT / VAGINALAB2025-12-08
A214137-002ESTRADIOLESTRADIOL0.01MGINSERT / VAGINALAB2025-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214137-001AB
A214137-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214137-001ESTRADIOL0.004MGINSERT / VAGINALAB2025-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214137-002ESTRADIOL0.01MGINSERT / VAGINALAB2025-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214137-001ESTRADIOL0.004MGINSERT / VAGINALAB2025-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214137-002ESTRADIOL0.01MGINSERT / VAGINALAB2025-12-0831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214137-001ESTRADIOL0.004MGINSERT / VAGINALAB2025-12-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214137-002ESTRADIOL0.01MGINSERT / VAGINALAB2025-12-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214137-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214137-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214137-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214137-002AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214137-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214137-002AB1a50c72e98297…

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 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLRedpharm Drug5718f042-e8c0-b721-e063-6294a90a5bef2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOLESTRADIOLA-S Medication Solutions5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLRedpharm Drug546c168d-2a85-69b6-e063-6294a90a22ac2026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLBryant Ranch Prepacke6bf2abc-71ae-4e79-a37b-164c98ba746a2026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutions34bcec8e-c7a6-4a1c-9884-4d4efe024bb92026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLREMEDYREPACK INC.41f7a56c-4ce3-4cc6-803e-1ff662efef902026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLREMEDYREPACK INC.59a4b68d-a507-4809-a0c8-fd9799986d122026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutionsba935918-39b3-4b56-bd83-78a29958e6d82026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutions1c38f0d0-a360-4b66-bc0e-7d54e92465a12026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOLESTRADIOLREMEDYREPACK INC.477cb52e-8ce2-491f-94a0-869ff60bf7ab2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutionseacafc4a-2fa8-403d-8df7-2bc92d73a54f2026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLA-S Medication Solutionsee5460ab-27e7-487a-a89c-bf8735399be62026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLREMEDYREPACK INC.774ee81b-8e29-46af-ab12-7157f63b443b2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstroGelESTRADIOLASCEND Therapeutics US, LLC762ac371-bb8b-47e7-b48f-e80d452c9dd42026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLA-S Medication Solutionsafd70875-0a93-40a7-842e-f4359818c2d92026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
EstradiolESTRADIOL GEL 0.1%Xiromed, LLC1a46efe6-21b9-3f0f-90b9-59f279ef51df2026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
ESTRADIOLESTRADIOLEncube Ethicals, Inc.54f108d6-ddd2-4276-8508-2c8e16a65fb22026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
Estradiol GelESTRADIOLEncube Ethicals, Inc.d4a3606f-83b2-45df-bc77-faebfa796f9a2026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstringESTRADIOLPfizer Laboratories Div Pfizer Inc110b9865-5a07-4d45-b560-e89947f126002026-04-23Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLA-S Medication Solutions0137d491-6917-4060-9b32-e0cd7b0badbb2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84743ORIG 2026-01-13