FDA.reportPublic FDA data

Application 078657

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESOXIMETASONEDESOXIMETASONEOINTMENT;TOPICAL0.25%NoNo

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
A078657-001DESOXIMETASONEDESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078657-001AB

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 22:54:322026-06A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078657-001AB1a50c72e98297…

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesoximetasoneDESOXIMETASONESaptalis Pharmaceuticals, LLC.827aee22-cf48-477c-8791-c74f16da954d2026-05-11Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DESOXIMETASONEDESOXIMETASONESaptalis Pharmaceuticals, LLC.c84c7168-3d46-4e05-a25c-3d594ff942682026-05-07Warnings, Adverse reactionsName fallback
brand name: DESOXIMETASONE
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEA-S Medication Solutions54743c9d-badd-47ce-bf86-6a8c398f7f072026-05-01Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEBryant Ranch Prepackfdee36f3-7630-4298-ab7c-f5f8ff7c4c042026-04-23Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
TopicortDESOXIMETASONESun Pharmaceutical Industries, Inc.96dfac6f-540f-4b7d-bcee-7e62088ebc932026-03-12Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONELupin Pharmaceuticals, Inc.b53727cf-a57f-443f-8036-3d4bd27375402025-11-25Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONELupin Pharmaceuticals, Inc.f53ddb86-bf8a-4bb3-b7ce-387fa78d90662025-11-24Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONELupin Pharmaceuticals, Inc.da2a8a3e-f187-4906-8fe3-246cc31de16f2025-11-24Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONELupin Pharmaceuticals, Inc.e4b648f4-c65d-44b3-a97a-657730f653222025-11-13Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DESOXIMETASONEDESOXIMETASONELupin Pharmaceuticals, Inc.65e5f3c5-ef24-4e21-9427-fa0d5c2830982025-11-05Warnings, Adverse reactionsName fallback
brand name: DESOXIMETASONE
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEThe J. Molner Company LLC2bbb5200-8355-ba86-e063-6394a90a23b62025-10-02Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.b046ab97-ba1a-4be6-a238-09670b38b3972025-07-08Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.627031fc-9b91-4854-b08f-f9fc0c73f1de2025-07-03Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.96898d55-aa50-4281-8c23-ec4738ede3942025-07-03Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.37eb1205-1743-4480-8631-b0bbcaeb83592025-07-02Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
TopicortDESOXIMETASONESun Pharmaceutical Industries, Inc.e417856a-b760-4626-bc34-8e4bc62c026c2025-07-02Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEBryant Ranch Prepack302fc53a-2779-4168-b76c-9ae0cf0b33312025-05-21Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEPadagis Israel Pharmaceuticals Ltd4ad6c159-4daa-4a33-8db6-351b5263323d2025-03-07Warnings, Adverse reactionsName fallback
brand name: Desoximetasone
generic name: DESOXIMETASONE
desoximetasoneDESOXIMETASONEBryant Ranch Prepackbd914203-d3bf-4f15-b2e4-715ff80e2a522024-12-24Warnings, Adverse reactionsName fallback
brand name: desoximetasone
generic name: DESOXIMETASONE
desoximetasoneDESOXIMETASONEZydus Lifesciences Limitedb780701b-5572-48bc-a5f4-00248eaddd3b2024-08-14Name fallback
brand name: desoximetasone
generic name: DESOXIMETASONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0151DesoximetasoneDesoximetasoneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0151DesoximetasoneDesoximetasoneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0151DesoximetasoneDesoximetasoneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent