FDA.reportPublic FDA data

Application 085691

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEOINTMENT;TOPICAL0.025%NoNo
002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEOINTMENT;TOPICAL0.5%NoNo
003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEOINTMENT;TOPICAL0.1%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085691-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982
A085691-002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982
A085691-003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A085691-001AT
A085691-002AT
A085691-003AT

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 22:54:322026-06A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A085691-001AT1a50c72e98297…
2026-08-01 22:54:322026-06A085691-002AT1a50c72e98297…
2026-08-01 22:54:322026-06A085691-003AT1a50c72e98297…

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
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAsclemed USA, Inc.b20c22b2-9a74-4b71-9015-40838fd2d1932026-03-10Adverse reactionsExact identifier
application applno (ANDA): 085691
application number: ANDA085691
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCa5cc640f-c72d-49fa-b970-906c9ffd86292026-01-28Adverse reactionsExact identifier
application applno (ANDA): 085691
application number: ANDA085691
ndc (product): 0168-0005
ndc (product): 0168-0006
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepackee274346-938b-4678-9146-486ca65bcba52024-01-15Adverse reactionsExact identifier
application applno (ANDA): 085691
application number: ANDA085691
ndc (product): 63629-8841

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0005Triamcinolone Acetonidetriamcinolone acetonideE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0006Triamcinolone Acetonidetriamcinolone acetonideE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
21695-503triamcinolone acetonidetriamcinolone acetonideRebel Distributors CorpANDACurrent
21695-504triamcinolone acetonidetriamcinolone acetonideRebel Distributors CorpANDACurrent
42254-176triamcinolone acetonidetriamcinolone acetonideRebel Distributors CorpANDACurrent
49999-216Triamcinolone Acetonidetriamcinolone acetonideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-216Triamcinolone Acetonidetriamcinolone acetonideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-216Triamcinolone Acetonidetriamcinolone acetonideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0163Triamcinolone Acetonidetriamcinolone acetonideA-S Medication SolutionsANDACurrent
50090-0240Triamcinolone Acetonidetriamcinolone acetonideA-S Medication SolutionsANDACurrent
63629-8841Triamcinolone Acetonidetriamcinolone acetonideBryant Ranch PrepackANDACurrent
63629-8841Triamcinolone Acetonidetriamcinolone acetonideBryant Ranch PrepackANDACurrent