Application 090506

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOMETASONE FUROATEMOMETASONE FUROATELOTION;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
A090506-001MOMETASONE FUROATEMOMETASONE FUROATE0.1%LOTION / TOPICAL2010-08-09

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 22:54:322026-06A090506-001MOMETASONE FUROATE0.1%LOTION / TOPICAL2010-08-09a50c72e98297…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEGlenmark Pharmaceuticals Inc., USA96eafc06-0354-49ca-a684-a77bb2afc8f52020-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090506
application number: ANDA090506
ndc (product): 68462-385

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-385Mometasone FuroateMometasone FuroateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-385Mometasone FuroateMometasone FuroateGlenmark Pharmaceuticals Inc., USAANDACurrent