FDA.reportPublic FDA data

Application 073517

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOPROFENKETOPROFENCAPSULE;ORAL75MGNoYes

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
A073517-001KETOPROFENKETOPROFEN75MGCAPSULE / ORAL1992-12-22

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 UTC2022-10A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A073517-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073517-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A073517-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073517-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073517-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073517-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073517-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073517-001AB1ea99ee380514…

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
KetoprofenKETOPROFENMarnel Pharmaceuticals, Inc.4e7bceb6-dcb5-c5e0-e063-6294a90a101e2026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoprofen
generic name: KETOPROFEN
KetoprofenKETOPROFENOncora Pharma, LLC492de5dc-7c1b-47be-8510-43be4e1fd4ed2026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoprofen
generic name: KETOPROFEN
KetoprofenKETOPROFENMisemer Pharmaceuticals, Inc.d0f47ab6-29ff-df07-e053-2a95a90a2b512026-02-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoprofen
generic name: KETOPROFEN
OrudisKETOPROFENAllegis Pharmaceuticals, Inc.47d0b808-7142-c7a9-e063-6394a90a6e0d2026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: KETOPROFEN
KetoprofenKETOPROFENMylan Pharmaceuticals Inc.198a4140-f4c0-4478-9157-ee1d68d0bb962024-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoprofen
generic name: KETOPROFEN

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-064KetoprofenKetoprofenAidarex Pharmaceuticals LLCANDACurrent
42254-037KetoprofenKetoprofenRebel Distributors CorpANDACurrent
45865-379KetoprofenKetoprofenMedsource PharmaceuticalsANDACurrent
63187-018KetoprofenKetoprofenProficient Rx LPANDACurrent
63187-018KetoprofenKetoprofenProficient Rx LPANDACurrent
63629-1836KetoprofenKetoprofenBryant Ranch PrepackANDACurrent
66267-126KetoprofenKetoprofenNuCare Pharmaceuticals, Inc.ANDACurrent
66267-126KetoprofenKetoprofenNuCare Pharmaceuticals, Inc.ANDACurrent
67296-0369KetoprofenKetoprofenRedPharm Drug Inc.ANDACurrent
68788-9088KetoprofenKetoprofenPreferred Pharmaceuticals, Inc.ANDACurrent