FDA.reportPublic FDA data

Application 050682

Type
NDA
Sponsor
RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COSMEGENDACTINOMYCININJECTABLE;INJECTION0.5MG/VIALYesYes

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
N050682-001COSMEGENDACTINOMYCIN0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982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 UTC2022-10N050682-001COSMEGEN0.5MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050682-001COSMEGEN0.5MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050682-001COSMEGEN0.5MG/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050682-001COSMEGEN0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050682-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050682-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050682-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050682-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050682-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050682-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050682-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N050682-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050682-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050682-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050682-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N050682-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050682-001AP1ea99ee380514…
2023-12-20 04:57 UTC2023-12N050682-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050682-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050682-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050682-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050682-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050682-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050682-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050682-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050682-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050682-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050682-001AP1cb3db0bc1861…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DACTINOMYCINDACTINOMYCINEugia US LLC5da55538-2602-4704-a9da-603c9f7ff7dc2024-06-18Warnings, Adverse reactionsName fallback
generic name: DACTINOMYCIN
dactinomycinDACTINOMYCINXGen Pharmaceuticals DJB, Inc.efe03d73-eb11-45ff-a3cb-09a540ed352f2024-05-28Warnings, Adverse reactionsName fallback
generic name: DACTINOMYCIN
DactinomycinDACTINOMYCINHisun Pharmaceuticals USA, Inc.95d5c152-aa00-41e6-83e8-8df374a564472024-05-08Warnings, Adverse reactionsName fallback
generic name: DACTINOMYCIN
DACTINOMYCINDACTINOMYCINEugia US LLCaa047ee8-f2e8-4720-84b1-d1c4532d6c632023-12-20Warnings, Adverse reactionsName fallback
generic name: DACTINOMYCIN
DactinomycinDACTINOMYCINMeitheal Pharmaceuticals Inc.2aaca42a-3b79-4151-a727-83253556a5402020-11-13Warnings, Adverse reactionsName fallback
generic name: DACTINOMYCIN

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55292-811CosmegendactinomycinRECORDATI RARE DISEASES, INC.NDACurrent
55292-811CosmegendactinomycinRecordati Rare Diseases, Inc.NDACurrent
55292-811CosmegendactinomycinRECORDATI RARE DISEASES, INC.NDACurrent
66993-489DactinomycinDactinomycinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-489DactinomycinDactinomycinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-489DactinomycinDactinomycinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56120SUPPL2018-10-26
56119SUPPL2018-10-26
55204SUPPL2018-08-17
55187SUPPL2018-08-16
30267SUPPL2012-02-07
7991SUPPL2012-02-07
39104SUPPL2012-02-06
18010SUPPL2012-02-06
18009SUPPL2009-04-03
7990SUPPL2009-03-17
7989SUPPL2005-08-19
7988SUPPL2004-12-06
7987SUPPL2003-03-26
30266SUPPL2002-10-28