FDA.reportPublic FDA data

Application 215096

Type
ANDA
Sponsor
LONG GROVE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLGEL, METERED;TRANSDERMAL0.06% (1.25GM/ACTIVATION)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215096-001ESTRADIOLESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMAL2026-02-02

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 22:38:342026-08A215096-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMAL2026-02-0284e616aacf4f…
2026-08-18 06:07:402026-07A215096-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMAL2026-02-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215096-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2026-02-02011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215096-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMAL2026-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215096-001AB1011fe1cb6892…

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 6 of 7 · 137 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLA-S Medication Solutions7f3c96ce-c855-4372-95ba-7759dd82bcca2024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.5423c0da-eb10-20cd-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
DOTTIESTRADIOLBryant Ranch Prepack99b889a0-6200-4727-97d3-f5a0b7814e1b2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLBryant Ranch Prepack9eb88585-4994-474f-bd63-c4e003bf6f202024-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLBryant Ranch Prepack7eb1b2c3-8ece-47c3-96c0-606f7f5b5a322024-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLBryant Ranch Prepackd9514497-6b9e-4c13-950b-6b036ff101c12024-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.1bbdb10b-9a32-3899-e063-6294a90ab26d2024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
ESTRADIOLESTRADIOLNuCare Pharmaceuticals,Inc.7093dbe4-b096-2ddb-e053-2991aa0a1bb82024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
ESTRACEESTRADIOLAllergan, Inc.dfc41fcd-c5ba-4b25-b647-cf04d3988b3e2024-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLAmneal Pharmaceuticals NY LLCd4259bb8-91f8-4587-8ceb-35d44145aec02024-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
LYLLANAESTRADIOLAmneal Pharmaceuticals LLC09c472c6-a38a-4a3d-b048-6fefd52e2ad32024-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
EstradiolESTRADIOLAmneal Pharmaceuticals NY LLC0500ee9b-bf4a-4432-9afe-20a7d60a6fe52024-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
DOTTIESTRADIOLAmneal Pharmaceuticals LLC53016d30-6b5f-49da-ac16-85ef415a58052024-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTRADIOL
ESTRADIOLESTRADIOLBryant Ranch Prepack0e927450-3f02-4d2f-9235-a255357e8d932024-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
ESTRADIOLESTRADIOLBryant Ranch Prepack6a4e82a4-d980-4c04-9e33-9444a292728a2024-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
ESTRADIOLESTRADIOLBryant Ranch Prepackeab9a629-b3d4-4faf-bce4-656fe3b46d382024-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ESTRADIOL
generic name: ESTRADIOL
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3fe899db-a8cd-4a31-88fb-1129be96b4d92024-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLNoven Therapeutics, LLCbf185599-2138-4083-9c52-2b95dce09ae02024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLBryant Ranch Prepack80d6644a-d6f2-48e7-a685-92c4255b19fe2024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Estradiol
generic name: ESTRADIOL
EstradiolESTRADIOLBryant Ranch Prepack414b846a-d6d9-4e8a-9632-12e296fc13c32024-04-04Boxed 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.