Application 207550

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEINJECTABLE;INJECTION40MG/MLNoNo

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
A207550-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207550-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-113f01610625f2…
2019-09-15 20:21 UTC2019-09A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONAB2017-12-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207550-001TRIAMCINOLONE ACETONIDE40MG/MLINJECTABLE / INJECTIONBX2017-12-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207550-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207550-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207550-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207550-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207550-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207550-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207550-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207550-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207550-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207550-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207550-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207550-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207550-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207550-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207550-001BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207550-001BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207550-001BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207550-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207550-001BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207550-001BX1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207550-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207550-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207550-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207550-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207550-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207550-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207550-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207550-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207550-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207550-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207550-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207550-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207550-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207550-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207550-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207550-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207550-001BX13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207550-001BX1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207550-001BX1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207550-001BX1cb3db0bc1861…

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLC6b6eed06-ff96-4ceb-bb0c-a67a149987a42026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
ndc (product): 70121-1657
ndc (product): 70121-1654
ndc (product): 70121-1655
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLCbf0b4d32-c8b7-48c9-a29b-3e7c2afc6cbf2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
ndc (product): 70121-1651
ndc (product): 70121-1652
ndc (product): 70121-1653
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENorthStar Rx LLC5f3aaf3a-cc66-4d4f-b9b7-2c50c325d4772026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
ndc (product): 16714-140
ndc (product): 16714-150
ndc (product): 16714-130
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLCcfae0704-e754-419b-bbdc-69e7867a8a5a2026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLC8d11aee3-b66e-439b-9188-7d91219a59cf2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.e55f3f0f-bd52-47e4-b77d-73ede1b414662026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLCc38dcd37-9840-4f71-a5c9-97380c8107f22026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
ndc (product): 70121-1168
ndc (product): 70121-1169
ndc (product): 70121-1049
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLC4e0ddecf-7ea1-4f42-9924-53fe5a5657ff2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEASCLEMED USA INC.1c6a740e-bc0d-41f3-b576-7d4c3880be232026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEASCLEMED USA INC.b909659e-8dd5-4652-89f4-c4d6b741a8552026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLCcab0573d-e760-4ff5-a69f-0ce06cfdb97a2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207550
application number: ANDA207550

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-130Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
16714-130Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
16714-130Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
16714-140Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
16714-140Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
16714-140Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
16714-150Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
16714-150Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
16714-150Triamcinolone AcetonideTriamcinolone AcetonideNorthStar Rx LLCANDACurrent
70121-1049Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70121-1049Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1049Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1049Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1168Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70121-1168Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1168Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1168Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1169Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70121-1169Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1169Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1169Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1651Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1651Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1651Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70121-1652Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1652Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1652Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70121-1653Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1653Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1653Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70121-1654Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1654Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1654Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70121-1655Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1655Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1655Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70121-1657Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1657Triamcinolone AcetonideTriamcinolone AcetonideAmneal Pharmaceuticals LLCANDACurrent
70121-1657Triamcinolone AcetonideTriamcinolone AcetonideAmneal Biosciences LLCANDACurrent
70518-1296Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-1296Triamcinolone AcetonideTriamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70529-048ProtherixTriamcinolone AcetonideIT3 Medical LLCANDACurrent
70529-048ProtherixTriamcinolone AcetonideIT3 Medical LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50988ORIG2018-01-08