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 43.

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
2026-09-14 22:38:342026-08A214137-001ESTRADIOL0.004MGINSERT / VAGINALAB2025-12-0884e616aacf4f…
2026-09-14 22:38:342026-08A214137-002ESTRADIOL0.01MGINSERT / VAGINALAB2025-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A214137-001ESTRADIOL0.004MGINSERT / VAGINALAB2025-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A214137-002ESTRADIOL0.01MGINSERT / VAGINALAB2025-12-08caaa826d4ba7…
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
2026-09-14 22:38:342026-08A214137-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A214137-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A214137-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214137-002AB1caaa826d4ba7…
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 2 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
EstradiolESTRADIOLPreferred Pharmaceuticals, Inc.6d129a94-8ecd-40a3-9a95-c5e1ece41ab12026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLBryant Ranch Prepack67f581cb-6d77-49fc-b2f3-976e3b57dcbf2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ClimaraESTRADIOLBayer HealthCare Pharmaceuticals Inc.1e9702c4-f2d7-4ea8-b6e8-7dca316718642026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
MenostarESTRADIOLBayer HealthCare Pharmaceuticals Inc.a78708cd-04d4-4221-a4e4-53680bbe29122026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estradiol Transdermal SystemESTRADIOLSandoz Incc714974b-766f-42f2-a846-b0c1f5a605602026-03-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLPadagis Israel Pharmaceuticals Ltd3ac905b3-904c-4285-97ed-e787d006c7dd2026-02-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
DIVIGELESTRADIOLVertical Pharmaceuticals, LLC59e610dc-883e-4f07-9ec6-a5841b0bf9fb2026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOL TRANSDERMALAmneal Pharmaceuticals NY LLC9669a0e3-27e2-4f6c-961c-7a67e9f84cc82026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
EstradiolESTRADIOLMylan Pharmaceuticals Inc.98770987-b313-4f2a-9aac-db0ab2068cc62026-02-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOLESTRADIOLREMEDYREPACK INC.170ec388-d399-4543-8743-208394b389042026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
EstradiolESTRADIOLSolaris Pharma Corporation67e8665c-5331-423c-99fd-546ab6cccb072026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
YuvafemESTRADIOLAvKAREd20abc9a-8f47-e274-c9b1-b71c9489761f2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estradiol VaginalESTRADIOLAvKAREbb7b442d-b8c3-b7f0-e053-2a95a90a2c942026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
Estradiol 1557ESTRADIOLProfessional Complementary Health Formulasf0da282a-6c7e-4a18-870f-d0d8efc2c7e92026-01-08WarningsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLDirect_Rx47e446f8-ac16-ea6b-e063-6394a90a17262026-01-08Boxed 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
84743ORIG 2026-01-13