FDA.reportPublic FDA data

Application 085692

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

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

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
A085692-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982
A085692-002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982
A085692-003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085692-001AT
A085692-002AT
A085692-003AT

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 22:54:322026-06A085692-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A085692-002TRIAMCINOLONE ACETONIDE0.5%CREAM / TOPICALATRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06A085692-003TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALATRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A085692-001AT1a50c72e98297…
2026-08-01 22:54:322026-06A085692-002AT1a50c72e98297…
2026-08-01 22:54:322026-06A085692-003AT1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEDIRECTRX835bbcd1-3869-646c-e053-2a91aa0a796a2026-03-17Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
ndc (product): 61919-650
triamcinolone acetonideTRIAMCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC92a1ded0-8e1a-4994-9c8a-89e84fc85c942026-01-28Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
ndc (product): 0168-0002
ndc (product): 0168-0003
ndc (product): 0168-0004
triamcinolone acetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.5701a07f-bd22-4bc7-95ff-0c5444ea59712025-10-01Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
triamcinolone acetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.5040eba2-2d00-496a-8773-66ba5440610f2025-06-27Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions2d6b9c2f-f1a0-413e-b333-64da523682022023-12-09Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
ndc (product): 50090-0293
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP41c1fe93-0509-4cf6-ac35-049028b731de2019-12-01Adverse reactionsExact identifier
application applno (ANDA): 085692
application number: ANDA085692
ndc (product): 63187-214
ndc (product): 63187-053

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0002triamcinolone acetonidetriamcinolone acetonideE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0003triamcinolone acetonidetriamcinolone acetonideE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0004triamcinolone acetonidetriamcinolone acetonideE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
21695-189Triamcinolone AcetonideTriamcinolone AcetonideRebel Distributors CorpANDACurrent
21695-501Triamcinolone AcetonideTriamcinolone AcetonideRebel Distributors CorpANDACurrent
21695-502Triamcinolone AcetonideTriamcinolone AcetonideRebel Distributors CorpANDACurrent
35356-658triamcinolone acetonidetriamcinolone acetonideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-0293triamcinolone acetonidetriamcinolone acetonideA-S Medication SolutionsANDACurrent
50090-0293triamcinolone acetonidetriamcinolone acetonideA-S Medication SolutionsANDACurrent
50090-0324triamcinolone acetonidetriamcinolone acetonideA-S Medication SolutionsANDACurrent
50436-0842triamcinolone acetonidetriamcinolone acetonideUnit Dose ServicesANDACurrent
61919-650TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEDIRECTRXANDACurrent
61919-650TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEDIRECTRXANDACurrent
63187-053Triamcinolone AcetonideTriamcinolone AcetonideProficient Rx LPANDACurrent
63187-053Triamcinolone AcetonideTriamcinolone AcetonideProficient Rx LPANDACurrent
63187-214Triamcinolone AcetonideTriamcinolone AcetonideProficient Rx LPANDACurrent
63187-214Triamcinolone AcetonideTriamcinolone AcetonideProficient Rx LPANDACurrent
68788-6795triamcinolone acetonidetriamcinolone acetonidePreferred PharmaceuticalsANDACurrent
70518-0136triamcinolone acetonidetriamcinolone acetonideREMEDYREPACK INC.ANDACurrent
70518-0136triamcinolone acetonidetriamcinolone acetonideREMEDYREPACK INC.ANDACurrent