Application 205082

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESOXIMETASONEDESOXIMETASONECREAM;TOPICAL0.25%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
A205082-001DESOXIMETASONEDESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205082-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-043f01610625f2…
2019-09-15 20:21 UTC2019-09A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04e64feba35796…

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 06:07:402026-07A205082-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205082-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205082-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205082-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205082-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205082-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205082-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205082-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205082-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205082-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205082-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205082-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205082-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205082-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205082-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205082-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205082-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205082-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205082-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205082-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205082-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205082-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205082-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205082-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205082-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205082-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205082-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205082-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205082-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205082-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205082-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205082-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205082-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205082-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205082-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205082-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205082-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205082-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205082-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205082-001AB1e64feba35796…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesoximetasoneDESOXIMETASONEProficient Rx LPf30b6fcc-43bc-4d65-9c3b-8d6ca780a0242022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205082
application number: ANDA205082
ndc (product): 71205-271

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0472-0478DesoximetasoneDesoximetasoneActavis Pharma, Inc.ANDACurrent
0472-0478DesoximetasoneDesoximetasoneActavis Pharma, Inc.ANDACurrent
50090-3919DesoximetasoneDesoximetasoneA-S Medication SolutionsANDACurrent
50090-3919DesoximetasoneDesoximetasoneA-S Medication SolutionsANDACurrent
53002-9280DesoximetasoneDesoximetasoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-9280DesoximetasoneDesoximetasoneRPK Pharmaceuticals, Inc.ANDACurrent
71205-271DesoximetasoneDesoximetasoneProficient Rx LPANDACurrent
71205-271DesoximetasoneDesoximetasoneProficient Rx LPANDACurrent
71205-271DesoximetasoneDesoximetasoneProficient Rx LPANDACurrent
71205-271DesoximetasoneDesoximetasoneProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10421ORIG2015-09-09