FDA.reportPublic FDA data

Application 078434

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.5%NoNo

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
A078434-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMIC2009-11-05

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 UTC2022-10A078434-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078434-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078434-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMICAT2009-11-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078434-001KETOROLAC TROMETHAMINE0.5%SOLUTION/DROPS / OPHTHALMIC2009-11-05a50c72e98297…

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 ZIP2022-06A078434-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078434-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078434-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078434-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078434-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078434-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078434-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A078434-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078434-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078434-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078434-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A078434-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078434-001AT1ea99ee380514…
2023-01-26 05:58 UTC2023-01A078434-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078434-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078434-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078434-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078434-001AT1cb3db0bc1861…

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
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals,Inc.c2290fd1-2985-1275-e053-2995a90ad5fa2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078434
application number: ANDA078434
ndc (product): 68071-2400
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LPfc8ba956-4d3d-4f52-ac8e-89d52a480b482021-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078434
application number: ANDA078434
ndc (product): 63187-628

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-209Ketorolac Tromethamineketorolac tromethamineAkornANDACurrent
17478-209Ketorolac Tromethamineketorolac tromethamineAkorn Inc.ANDACurrent
17478-209Ketorolac Tromethamineketorolac tromethamineAkorn Inc.ANDACurrent
35356-771Ketorolac Tromethamineketorolac tromethamineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1142Ketorolac Tromethamineketorolac tromethamineA-S Medication SolutionsANDACurrent
50436-6195Ketorolac Tromethamineketorolac tromethamineUnit Dose ServicesANDACurrent
63187-628Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
63187-628Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
63187-628Ketorolac Tromethamineketorolac tromethamineProficient Rx LPANDACurrent
68071-2400Ketorolac Tromethamineketorolac tromethamineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9321Ketorolac Tromethamineketorolac tromethaminePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31367ORIG2009-11-12