FDA.reportPublic FDA data

Application 081203

Type
ANDA
Sponsor
FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONEHYDROCORTISONEOINTMENT;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
A081203-001HYDROCORTISONEHYDROCORTISONE2.5%OINTMENT / TOPICALATRS1993-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A081203-001AT

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 22:54:322026-06A081203-001HYDROCORTISONE2.5%OINTMENT / TOPICALATRS1993-05-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A081203-001AT1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCbcd103f3-3dc8-4394-b8fd-8f8ddb721f772026-01-28Adverse reactionsExact identifier
application applno (ANDA): 081203
application number: ANDA081203
ndc (product): 0168-0146
HydrocortisoneHYDROCORTISONEBryant Ranch Prepackc4013d86-e134-43c3-ad75-7e680a9d2ae72024-01-11Adverse reactionsExact identifier
application applno (ANDA): 081203
application number: ANDA081203
ndc (product): 63629-8817

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0146HydrocortisoneHydrocortisoneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0146HydrocortisoneHydrocortisoneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
53002-8780HydrocortisoneHydrocortisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-8780HydrocortisoneHydrocortisoneRPK Pharmaceuticals, Inc.ANDACurrent
63629-8817HydrocortisoneHydrocortisoneBryant Ranch PrepackANDACurrent
63629-8817HydrocortisoneHydrocortisoneBryant Ranch PrepackANDACurrent
68071-1581HydrocortisoneHydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1581HydrocortisoneHydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent