FDA.reportPublic FDA data

Application 018309

Type
NDA
Sponsor
TARO PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPICORT LPDESOXIMETASONECREAM;TOPICAL0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018309-001TOPICORT LPDESOXIMETASONE0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018309-001TOPICORT LP0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018309-001TOPICORT LP0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018309-001TOPICORT LP0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018309-001TOPICORT LP0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982a50c72e98297…

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesoximetasoneDESOXIMETASONESaptalis Pharmaceuticals, LLC.827aee22-cf48-477c-8791-c74f16da954d2026-05-11Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DESOXIMETASONEDESOXIMETASONESaptalis Pharmaceuticals, LLC.c84c7168-3d46-4e05-a25c-3d594ff942682026-05-07Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEA-S Medication Solutions54743c9d-badd-47ce-bf86-6a8c398f7f072026-05-01Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEBryant Ranch Prepackfdee36f3-7630-4298-ab7c-f5f8ff7c4c042026-04-23Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
TopicortDESOXIMETASONESun Pharmaceutical Industries, Inc.96dfac6f-540f-4b7d-bcee-7e62088ebc932026-03-12Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONELupin Pharmaceuticals, Inc.b53727cf-a57f-443f-8036-3d4bd27375402025-11-25Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONELupin Pharmaceuticals, Inc.f53ddb86-bf8a-4bb3-b7ce-387fa78d90662025-11-24Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONELupin Pharmaceuticals, Inc.da2a8a3e-f187-4906-8fe3-246cc31de16f2025-11-24Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONELupin Pharmaceuticals, Inc.e4b648f4-c65d-44b3-a97a-657730f653222025-11-13Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DESOXIMETASONEDESOXIMETASONELupin Pharmaceuticals, Inc.65e5f3c5-ef24-4e21-9427-fa0d5c2830982025-11-05Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEThe J. Molner Company LLC2bbb5200-8355-ba86-e063-6394a90a23b62025-10-02Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.b046ab97-ba1a-4be6-a238-09670b38b3972025-07-08Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.627031fc-9b91-4854-b08f-f9fc0c73f1de2025-07-03Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.96898d55-aa50-4281-8c23-ec4738ede3942025-07-03Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.37eb1205-1743-4480-8631-b0bbcaeb83592025-07-02Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
TopicortDESOXIMETASONESun Pharmaceutical Industries, Inc.e417856a-b760-4626-bc34-8e4bc62c026c2025-07-02Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
DesoximetasoneDESOXIMETASONEBryant Ranch Prepack302fc53a-2779-4168-b76c-9ae0cf0b33312025-05-21Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
desoximetasoneDESOXIMETASONEBryant Ranch Prepackbd914203-d3bf-4f15-b2e4-715ff80e2a522024-12-24Warnings, Adverse reactionsName fallback
generic name: DESOXIMETASONE
desoximetasoneDESOXIMETASONEZydus Lifesciences Limitedb780701b-5572-48bc-a5f4-00248eaddd3b2024-08-14Name fallback
generic name: DESOXIMETASONE
desoximetasoneDESOXIMETASONEZydus Lifesciences Limited959e396a-2458-43b5-b412-db1974d58d8d2024-08-14Name fallback
generic name: DESOXIMETASONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33475SUPPL2004-05-04
898SUPPL2004-04-29