FDA.reportPublic FDA data

Application 078305

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCIPOTRIENECALCIPOTRIENESOLUTION;TOPICAL0.005%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
A078305-001CALCIPOTRIENECALCIPOTRIENE0.005%SOLUTION / TOPICALAT2008-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078305-001AT

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 22:54:322026-06A078305-001CALCIPOTRIENE0.005%SOLUTION / TOPICALAT2008-05-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078305-001AT1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalcipotrieneCALCIPOTRIENESun Pharmaceutical Industries, Inc.277d843a-0ea9-429d-813d-49ed72dafb642026-07-14Adverse reactionsName fallback
brand name: Calcipotriene
generic name: CALCIPOTRIENE
CalcitreneCALCIPOTRIENESun Pharmaceutical Industries, Inc.94d4f46a-f254-4fe2-b4bd-7a533d6324fe2026-07-14Adverse reactionsName fallback
generic name: CALCIPOTRIENE
PellixCALCIPOTRIENEPerfero Pharma, Inc.492ea9cf-0117-4d84-a964-9c0121706ed32026-05-04Warnings, Adverse reactionsName fallback
generic name: CALCIPOTRIENE
CalcipotrieneCALCIPOTRIENEGlenmark Pharmaceuticals Inc., USA1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc2026-01-23Warnings, Adverse reactionsName fallback
brand name: Calcipotriene
generic name: CALCIPOTRIENE
calcipotrieneCALCIPOTRIENEGlenmark Pharmaceuticals Inc.,USA7ec750f6-26ea-46bc-aa7b-174fd25253a22025-10-27Warnings, Adverse reactionsName fallback
brand name: calcipotriene
generic name: CALCIPOTRIENE
calcipotrieneCALCIPOTRIENENorthstar Rx LLCa882ef4f-603e-4421-97ae-2c78822c767a2024-06-24Warnings, Adverse reactionsName fallback
brand name: calcipotriene
generic name: CALCIPOTRIENE
calcipotrieneCALCIPOTRIENEMayne Pharma26756ac7-a80c-49db-97bb-351f76ad8a712024-05-09Warnings, Adverse reactionsName fallback
brand name: calcipotriene
generic name: CALCIPOTRIENE
SORILUXCALCIPOTRIENEMayne Pharma51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe2024-05-09Warnings, Adverse reactionsName fallback
generic name: CALCIPOTRIENE
CalcipotrieneCALCIPOTRIENEPrasco Laboratories377eafda-737c-4ba2-9ec5-61209b8814ed2022-12-12Warnings, Adverse reactionsName fallback
brand name: Calcipotriene
generic name: CALCIPOTRIENE
CalcipotrieneCALCIPOTRIENECosette Pharmaceuticals, Inc.21378c25-5622-8bf7-1a8c-b05940a846a02022-11-15Warnings, Adverse reactionsName fallback
brand name: Calcipotriene
generic name: CALCIPOTRIENE
calcipotrieneCALCIPOTRIENEPrasco Laboratoriesfe7cd92a-f066-4c4a-80c8-e3f929ad41812020-08-07Warnings, Adverse reactionsName fallback
brand name: calcipotriene
generic name: CALCIPOTRIENE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0400CalcipotrieneCalcipotrieneFougera Pharmaceuticals Inc.ANDACurrent
0168-0400CalcipotrieneCalcipotrieneFougera Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9140ORIG2008-05-08