FDA.reportPublic FDA data

Application 211315

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211315-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18
A211315-002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18

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.

Product history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-184b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211315-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICAL2020-03-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A211315-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2020-03-18782e0a99824c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack04ef72a9-6aa1-4d64-b598-f281215229a42026-08-25Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack20fa27ca-807a-4513-8af5-a835541d60d52026-08-24Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESagent Pharmaceuticals7dbee70b-bd11-4430-b626-97fbb8f01b492026-08-14Warnings, Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
CHILDRENS TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAurohealth LLC9e50af36-59f1-4f08-a0d7-7566f0a110342026-08-13WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAurohealth LLCa74eff58-bce4-4785-b583-3e474f8250702026-08-13WarningsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack3a85b137-7ef0-4b1d-8590-69c139355a132026-08-10Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackb2ba93bc-3775-466b-8daf-4ffa3edc9c002026-08-10Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackf152b99c-5363-40f9-9fad-c3e36b7c3df12026-08-10Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TriadermexTRIAMCINOLONE ACETONIDEFlorrax Pharmaceutical3bda5cd1-df3c-4b4c-9868-cbc41f66f5a62026-08-06Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Nasal AllergyTRIAMCINOLONE ACETONIDEHyVee Inc5ad719a7-3872-4d0c-93e6-603e4653ec422026-08-05WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.3051aa96-b12a-4a1d-947d-9b769bca8dc82026-07-31Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
KENALOG-10TRIAMCINOLONE ACETONIDEA-S Medication Solutions653ec195-0966-478d-be47-6b1ff158e1112026-07-30Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.3d495acf-8085-4aaa-8fc5-594b88c25c212026-07-13Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLC20c1234b-6749-422d-9420-9d5a98f5f30a2026-07-13Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCccca8660-124e-4220-8d87-4b9aeecbda7d2026-07-13Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.db87426f-124c-4ea9-bb15-fc3a0da10a4e2026-07-07Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.6a31a0c3-2b6e-40e3-b5ea-5c665afd35672026-07-06Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions089a8449-7810-48ec-b327-494f058c33482026-06-22Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLC6b6eed06-ff96-4ceb-bb0c-a67a149987a42026-06-18Warnings, Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLCbf0b4d32-c8b7-48c9-a29b-3e7c2afc6cbf2026-06-17Warnings, Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE

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
64380-870Triamcinolone AcetonideTriamcinolone AcetonideStrides Pharma Science LimitedANDACurrent
64380-871Triamcinolone AcetonideTriamcinolone AcetonideStrides Pharma Science LimitedANDACurrent