FDA.reportPublic FDA data

Application 085979

Type
ANDA
Sponsor
SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAMOSONEHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDELOTION;TOPICAL2.5%;1%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A085979-001PRAMOSONEHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE2.5%;1%LOTION / TOPICALApproved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A085979-001PRAMOSONE2.5%;1%LOTION / TOPICALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085979-001PRAMOSONE2.5%;1%LOTION / TOPICALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085979-001PRAMOSONE2.5%;1%LOTION / TOPICALApproved before 1982a50c72e98297…

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
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.3e5c6728-ece3-40f7-9e36-cff71f168cd82026-03-24Adverse reactionsExact identifier
application applno (ANDA): 085979
application number: ANDA085979
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.1469733e-1723-4b8c-be33-ed8dfafd65e22025-11-08Adverse reactionsExact identifier
application applno (ANDA): 085979
application number: ANDA085979
ndc (product): 54766-829
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.56568e1f-974b-4750-b560-d93eb5e0e83f2025-06-09Adverse reactionsExact identifier
application applno (ANDA): 085979
application number: ANDA085979
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.4c98a01e-ff11-45eb-8732-4bd9157969e82025-06-09Adverse reactionsExact identifier
application applno (ANDA): 085979
application number: ANDA085979

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54766-726Pramosonehydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDACurrent
54766-829Analpram HChydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDACurrent