FDA.reportPublic FDA data

Application 085368

Type
ANDA
Sponsor
SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAMOSONEHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDECREAM;TOPICAL1%;1%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
A085368-001PRAMOSONEHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE1%;1%CREAM / 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 · 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 UTC2022-10A085368-001PRAMOSONE1%;1%CREAM / TOPICALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085368-001PRAMOSONE1%;1%CREAM / TOPICALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085368-001PRAMOSONE1%;1%CREAM / TOPICALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085368-001PRAMOSONE1%;1%CREAM / 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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pramosone CreamHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.6a9fb75b-a2f7-4eca-8dce-d7eb5c1224762025-06-30Adverse reactionsExact identifier
application applno (ANDA): 085368
application number: ANDA085368
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDELegacy Pharma USA Inc.39618fc5-87a8-47bc-93fc-cb97b8f663c82025-06-24Adverse reactionsExact identifier
application applno (ANDA): 085368
application number: ANDA085368
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack0c28458a-cc56-4eea-89aa-d60659bd95682023-08-17Adverse reactionsExact identifier
application applno (ANDA): 085368
application number: ANDA085368
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack3c5e1833-9908-4e4f-bdf2-7a28c14a585c2023-07-18Adverse reactionsExact identifier
application applno (ANDA): 085368
application number: ANDA085368
ndc (product): 63629-8669
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd9eea5875-d153-4bba-aee2-b1d1cd8b5e572022-05-31Adverse reactionsExact identifier
application applno (ANDA): 085368
application number: ANDA085368
ndc (product): 45802-144

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-144hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclPadagis Israel Pharmaceuticals LtdANDACurrent
45802-144hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclPerrigo New York IncANDACurrent
54766-716Pramosone Creamhydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDACurrent
54766-778Analpram HChydrocortisone acetate and pramoxine hydrochlorideSebela Pharmaceuticals Inc.ANDACurrent
63629-8669hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclBryant Ranch PrepackANDACurrent
63629-8669hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclBryant Ranch PrepackANDACurrent
63629-8669hydrocortisone acetate pramoxine hclhydrocortisone acetate pramoxine hclBryant Ranch PrepackANDACurrent