FDA.reportPublic FDA data

Application 089414

Type
ANDA
Sponsor
FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONEHYDROCORTISONECREAM;TOPICAL2.5%NoYes

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
A089414-001HYDROCORTISONEHYDROCORTISONE2.5%CREAM / TOPICALATRS1986-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089414-001AT

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 22:54:322026-06A089414-001HYDROCORTISONE2.5%CREAM / TOPICALATRS1986-12-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A089414-001AT1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONESportpharm LLCef9cf62a-5805-48bc-915e-c0e91a10837e2026-04-24Adverse reactionsExact identifier
application applno (ANDA): 089414
application number: ANDA089414
Hydrocortisone CreamHYDROCORTISONE CREAMDirect_Rx364af43e-c1a9-3f03-e063-6294a90a14f52026-03-17Adverse reactionsExact identifier
application applno (ANDA): 089414
application number: ANDA089414
HydrocortisoneHYDROCORTISONEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCbcd103f3-3dc8-4394-b8fd-8f8ddb721f772026-01-28Adverse reactionsExact identifier
application applno (ANDA): 089414
application number: ANDA089414
ndc (product): 0168-0080

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
0168-0080HydrocortisoneHydrocortisoneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0080HydrocortisoneHydrocortisoneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
21695-206HydrocortisoneHydrocortisoneRebel Distributors CorpANDACurrent
49999-162HydrocortisoneHydrocortisoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-3434HydrocortisoneHydrocortisoneA-S Medication SolutionsANDACurrent
50436-2143HydrocortisoneHydrocortisoneUnit Dose ServicesANDACurrent
68071-2897HydrocortisoneHydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent