FDA.reportPublic FDA data

Application 212976

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOCINONIDEFLUOCINONIDEOINTMENT;TOPICAL0.05%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
A212976-001FLUOCINONIDEFLUOCINONIDE0.05%OINTMENT / TOPICALAB2019-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212976-001AB

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 22:54:322026-06A212976-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2019-11-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212976-001AB1a50c72e98297…

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluocinonideFLUOCINONIDEBryant Ranch Prepack9bad56f2-6070-44fc-a39d-bb00280057f02026-06-01Adverse reactionsExact identifier
application applno (ANDA): 212976
application number: ANDA212976
FluocinonideFLUOCINONIDEBryant Ranch Prepack4fbb3f39-c856-4da6-90b1-a6749de892c52024-01-10Adverse reactionsExact identifier
application applno (ANDA): 212976
application number: ANDA212976
ndc (product): 63629-2339
FluocinonideFLUOCINONIDEBryant Ranch Prepack9ee44ed9-e274-4673-8829-0032a36e5b792024-01-10Adverse reactionsExact identifier
application applno (ANDA): 212976
application number: ANDA212976
ndc (product): 63629-2337
FluocinonideFLUOCINONIDEBryant Ranch Prepack0a1dab63-17d0-4ae7-890b-7746be65e29b2024-01-10Adverse reactionsExact identifier
application applno (ANDA): 212976
application number: ANDA212976
ndc (product): 63629-2338
FluocinonideFLUOCINONIDEXiromed LLCd96cc4fd-abd3-1ce1-ac63-5d68a8332ecc2020-01-13Adverse reactionsExact identifier
application applno (ANDA): 212976
application number: ANDA212976
ndc (product): 70700-146

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2337FluocinonideFluocinonideBryant Ranch PrepackANDACurrent
63629-2337FluocinonideFluocinonideBryant Ranch PrepackANDACurrent
63629-2338FluocinonideFluocinonideBryant Ranch PrepackANDACurrent
63629-2338FluocinonideFluocinonideBryant Ranch PrepackANDACurrent
63629-2339FluocinonideFluocinonideBryant Ranch PrepackANDACurrent
63629-2339FluocinonideFluocinonideBryant Ranch PrepackANDACurrent
70700-146FluocinonideFluocinonideXiromed LLCANDACurrent
70700-146FluocinonideFluocinonideXiromed LLCANDACurrent
70700-146FluocinonideFluocinonideXiromed LLCANDACurrent
70700-146FluocinonideFluocinonideXiromed LLCANDACurrent