FDA.reportPublic FDA data

Application 206572

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFLORASONE DIACETATEDIFLORASONE DIACETATEOINTMENT;TOPICAL0.05%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A206572-001DIFLORASONE DIACETATEDIFLORASONE DIACETATE0.05%OINTMENT / TOPICAL2015-07-24

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A206572-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICAL2015-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206572-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICAL2015-07-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206572-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICAL2015-07-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206572-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICAL2015-07-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A206572-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206572-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206572-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206572-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206572-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206572-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206572-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206572-001AB1ea99ee380514…

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diflorasone DiacetateDIFLORASONE DIACETATESun Pharmaceutical Industries, Inc.b20c9420-8fb4-4a49-93f0-c0e4074d6d712025-09-22Adverse reactionsName fallback
brand name: Diflorasone Diacetate
generic name: DIFLORASONE DIACETATE
Diflorasone DiacetateDIFLORASONE DIACETATESun Pharmaceutical Industries, Inc.b304dfca-e840-4c03-8217-73aaa53602772025-07-03Adverse reactionsName fallback
brand name: Diflorasone Diacetate
generic name: DIFLORASONE DIACETATE
psorconDIFLORASONE DIACETATESun Pharmaceutical Industries, Inc.de40cc65-f955-423f-9cbd-bc2245c4f9822025-07-02Adverse reactionsName fallback
generic name: DIFLORASONE DIACETATE
Diflorasone DiacetateDIFLORASONE DIACETATERising Pharma Holdings, Inc.23eb27a4-157f-4eb5-a390-37586710808f2023-05-02Adverse reactionsName fallback
brand name: Diflorasone Diacetate
generic name: DIFLORASONE DIACETATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61748-350Diflorasone DiacetateDiflorasone DiacetateVersaPharm IncorporatedANDACurrent