FDA.reportPublic FDA data

Application 077061

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOMETASONE FUROATEMOMETASONE FUROATEOINTMENT;TOPICAL0.1%NoNo

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

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
A077061-001MOMETASONE FUROATEMOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2005-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077061-001AB

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
2026-08-01 22:54:322026-06A077061-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2005-03-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077061-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.831f7694-8153-4a79-a453-48020b26f0352026-07-17Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.bfe3d098-a5f8-4e5d-9fa6-eac167bad3e92026-07-17Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
ASMANEXMOMETASONE FUROATEOrganon LLC10b36fb2-6b0d-4f20-b197-3564d6f594b92026-07-07Warnings, Adverse reactionsName fallback
generic name: MOMETASONE FUROATE
ASMANEX HFAMOMETASONE FUROATEOrganon LLC0c6d63da-41bc-4894-bead-198e66c848ac2026-07-07Warnings, Adverse reactionsName fallback
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack5eda1256-001a-4f40-b3ca-15349d5320332026-05-21Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATETorrent Pharmaceuticals Limited18ef90de-f74d-492f-a125-49da1875bd292026-05-08Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone furoateMOMETASONE FUROATEEncube Ethicals, Inc.dae3eaea-fc17-48a2-ae30-2a68f7811bce2026-04-06Warnings, Adverse reactionsName fallback
brand name: Mometasone furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATESportpharm LLCf02dea3f-9e4f-4c5a-bea3-f428afca803b2026-03-19Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.ad47cceb-e471-48d6-85d6-e4a3f10e2ac62026-01-27Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEA-S Medication Solutions16e134c7-39fb-4d16-9c24-a6df438967bf2026-01-23Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
ALLERGY RELIEFMOMETASONE FUROATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED97681a68-c26a-4ec9-ac67-4480878fa43d2026-01-05WarningsName fallback
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepackc953bd40-8a52-4812-837a-baaf1b17b3aa2025-10-29Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack88f5622d-64da-42b7-8aa9-62a5da5ebfbb2025-10-24Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
MOMETASONE FUROATEMOMETASONE FUROATEEncube Ethicals, Inc.1ebaac16-432e-4e92-9d58-718bd76ae3682025-09-15Warnings, Adverse reactionsName fallback
brand name: MOMETASONE FUROATE
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack79e13e15-5bd3-48b1-877a-1cd92abbc7c52025-09-08Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack2f79063c-f7da-4e71-b054-d24b86dd386a2025-09-05Warnings, Adverse reactionsName fallback
brand name: Mometasone Furoate
generic name: MOMETASONE FUROATE
NasonexMOMETASONE FUROATEL. Perrigo Company13696a8b-366a-4a5e-adea-d5b7bff9e46f2025-08-19WarningsName fallback
generic name: MOMETASONE FUROATE
Leader Allergy NasalMOMETASONE FUROATECardinal Health 110, LLC. dba Leader26f929e8-0759-4584-a0bf-f7709baa6bee2025-08-11WarningsName fallback
generic name: MOMETASONE FUROATE
Rugby mometasone furoate nasalMOMETASONE FUROATERugby Laboratoriesb4c43535-ad22-44c2-b04f-df4348a6c4852025-08-06WarningsName fallback
generic name: MOMETASONE FUROATE
MOMETASONE FUROATEMOMETASONE FUROATEGolden State Medical Supply, Inc.e30ca373-d9c0-4cad-b5c3-3be9c299dddc2025-07-10Warnings, Adverse reactionsName fallback
brand name: MOMETASONE FUROATE
generic name: MOMETASONE FUROATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0271Mometasone Furoatemometasone furoateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0271Mometasone Furoatemometasone furoateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0271Mometasone Furoatemometasone furoateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
70518-0175Mometasone Furoatemometasone furoateREMEDYREPACK INC.ANDACurrent
70518-0175Mometasone Furoatemometasone furoateREMEDYREPACK INC.ANDACurrent