FDA.reportPublic FDA data

Application 217460

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOMETASONE FUROATEMOMETASONE FUROATESPRAY, METERED;NASAL0.05MG/SPRAYNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A217460-001MOMETASONE FUROATEMOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14

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
2026-08-18 06:07:402026-07A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-148072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217460-001MOMETASONE FUROATE0.05MG/SPRAYSPRAY, METERED / NASAL2023-06-14a50c72e98297…

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEPadagis Israel Pharmaceuticals Ltda12fef6b-681e-4f80-8bcd-3f01733f1a672025-07-07Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATESun Pharmaceutical Industries, Inc.ce61920d-65df-4423-925d-091e624ea32e2025-07-07Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
MOMETASONE FUROATEMOMETASONE FUROATEApotex Corp.48f7ba0d-33e0-163b-2fa0-f85062768fd52025-04-01Warnings, Adverse reactionsName fallback
brand name: MOMETASONE FUROATE
generic name: MOMETASONE FUROATE
MOMETASONE FUROATEMOMETASONE FUROATEAurohealth LLC48ba8c52-73b6-4ee9-ba13-756a645a91832024-11-25WarningsName fallback
brand name: MOMETASONE FUROATE
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack43a91066-1d85-4f67-9856-a11c1bb2b22b2024-11-20Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack6c7d8133-b71e-4290-bec1-53ff0232998a2024-08-30Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Childrens NasonexMOMETASONE FUROATEL. Perrigo Companye15d055e-9a25-46b4-8724-3609cf2dc0622024-08-28WarningsName fallback
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack45c9512b-9463-4684-bfdb-742644d77cc32024-08-14Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEProficient Rx LP2bf06b19-4ed7-41a3-b6fc-29713c41965c2024-02-01Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATECosette Pharmaceuticals, Inc.f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d922023-11-29Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATECosette Pharmaceuticals, Inc.f5b30e5e-b067-e28c-b7c5-aa58f4c57f092023-11-29Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepackc3053a64-9044-496e-9005-12b4440d46e82023-10-20Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepackd15edb8b-c8b2-4023-992e-f79cefa2d1e82023-08-16Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepacka6055a9c-e19c-48ad-a743-c0a7f7366cdd2023-07-18Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack5f1f2136-9e10-4d43-bb35-ed285c744fe42023-07-18Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEPadagis Israel Pharmaceuticals Ltd7296b4a2-f180-4887-a8e0-029f81aec5662023-04-21Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEA-S Medication Solutions9fe65193-b4d8-480b-89b3-178cd1b207132023-02-15Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
SinuvaMOMETASONE FUROATEIntersect ENT, Inc.e33c1b23-cdc6-4f64-94ba-24b0b42c09bf2023-01-26Warnings, Adverse reactionsName fallback
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEPadagis Israel Pharmaceuticals Ltdd986282f-da3c-43b6-a3f6-40886d4a19152023-01-01Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONEAmneal Pharmaceuticals LLCff41e901-5a6f-4ad5-be8a-a68eae787e5e2022-08-20Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate