FDA.reportPublic FDA data

Application 076884

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALCLOMETASONE DIPROPIONATEALCLOMETASONE DIPROPIONATEOINTMENT;TOPICAL0.05%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
A076884-001ALCLOMETASONE DIPROPIONATEALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALABRS2005-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076884-001AB

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 22:54:322026-06A076884-001ALCLOMETASONE DIPROPIONATE0.05%OINTMENT / TOPICALABRS2005-07-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076884-001AB1a50c72e98297…

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alclometasone DipropionateALCLOMETASONE DIPROPIONATESun Pharmaceutical Industries, Inc.3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c2025-08-13Adverse reactionsName fallback
brand name: Alclometasone Dipropionate
generic name: ALCLOMETASONE DIPROPIONATE
Alclometasone dipropionateALCLOMETASONE DIPROPIONATESun Pharmaceutical Industries, Inc.3e688309-880a-4890-bf00-90afd19084f62025-07-29Adverse reactionsName fallback
brand name: Alclometasone dipropionate
generic name: ALCLOMETASONE DIPROPIONATE
Alclometasone DipropionateALCLOMETASONE DIPROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab2025-07-09Adverse reactionsName fallback
brand name: Alclometasone Dipropionate
generic name: ALCLOMETASONE DIPROPIONATE
Alclometasone DipropionateALCLOMETASONE DIPROPIONATEGlenmark Pharmaceuticals Inc., USA63e635e0-65d8-4b30-9f2a-ab16deba90bd2021-04-05Adverse reactionsName fallback
brand name: Alclometasone Dipropionate
generic name: ALCLOMETASONE DIPROPIONATE

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
0168-0264Alclometasone Dipropionatealclometasone dipropionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0264Alclometasone Dipropionatealclometasone dipropionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0264Alclometasone Dipropionatealclometasone dipropionateE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent