Application 205373

Type
ANDA
Sponsor
TELIGENT PHARMA INC

Application Products#

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

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

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
A205373-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205373-001AT

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205373-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205373-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205373-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205373-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205373-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205373-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205373-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205373-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205373-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205373-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205373-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205373-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205373-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205373-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205373-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205373-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205373-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205373-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205373-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205373-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205373-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205373-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A205373-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205373-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205373-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205373-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A205373-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205373-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205373-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205373-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205373-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205373-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205373-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205373-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205373-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205373-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205373-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205373-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205373-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205373-001AT1e64feba35796…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.6a31a0c3-2b6e-40e3-b5ea-5c665afd35672026-07-06Adverse reactionsExact identifier
application applno (ANDA): 205373
application number: ANDA205373
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEA-S Medication Solutionsf65c5847-365e-44b0-a756-1b16788684db2025-10-09Adverse reactionsExact identifier
application applno (ANDA): 205373
application number: ANDA205373

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
52565-014Triamcinolone Acetonidetriamcinolone acetonideTeligent Pharma, Inc.ANDACurrent
52565-014Triamcinolone Acetonidetriamcinolone acetonideTeligent Pharma, Inc.ANDACurrent
59088-733Sila IIItriamcinolone acetonidePureTek CorporationANDACurrent
59088-841Treziopaktriamcinolone acetonidePureTek CorporationANDACurrent
59088-841Treziopaktriamcinolone acetonidePureTek CorporationANDACurrent
59088-843Juulissa Pharmapaktriamcinolone acetonidePureTek CorporationANDACurrent
59088-846Ellzia Paktriamcinolone acetonide, dimethiconePureTek CorporationANDACurrent
68071-1784Triamcinolone Acetonidetriamcinolone acetonideNuCare Pharmaceuticals,Inc.ANDACurrent
69621-841SilaLite Paktriamcinolone acetonideShoreline PharmaceuticalsANDACurrent
69621-846Yaliira Paktriamcinolone acetonide, dimethiconeShoreline PharmaceuticalsANDACurrent
70518-1111Triamcinolone Acetonidetriamcinolone acetonideREMEDYREPACK INC.ANDACurrent
70518-1111Triamcinolone Acetonidetriamcinolone acetonideREMEDYREPACK INC.ANDACurrent