FDA.reportPublic FDA data

Application 074754

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINETABLET;ORAL10MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074754-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074754-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074754-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.f47d4365-40a8-445b-99cd-49edad6a8ffc2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINESportpharm LLC0749f61d-12e6-4280-8f41-bd4df81e7ae62026-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENorthwind Health Company, LLCd17ed469-677b-4a2e-96a9-5cfd0f50ecd92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAmerican Health Packaging48244614-53ec-47e6-ad48-50814bdcceb72025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEPD-Rx Pharmaceuticals, Inc.add10ccd-c205-4512-9619-253290fa11522025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions9fdba2e6-969f-4624-b08b-a42f99e4eff92025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAdvanced Rx Pharmacy of Tennessee, LLCc1717245-cef3-b3d7-e053-2a95a90a1ac52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
ndc (product): 80425-0139
Ketorolac TromethamineKETOROLAC TROMETHAMINETeva Pharmaceuticals USA, Inc.688f5dec-a6db-43c6-a1f8-5df99d08d3952024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.415a5393-296f-30e3-e054-00144ff8d46c2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.46dc8f62-e754-50e3-e054-00144ff8d46c2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepackf713500a-20b8-8e20-c4cc-9568051703352023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.94c7c57a-fd1e-41ab-bc39-9a538f6011d12023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
ndc (product): 76420-032
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LPf5170993-81a9-4eb7-95ac-60697a5ee1d72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 86 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
76413-109Ketorolac TromethamineKetorolac TromethamineCentral Texas Community Health CentersANDACurrent
76420-032Ketorolac TromethamineKetorolac TromethamineAsclemed USA, Inc.ANDACurrent
76420-032Ketorolac TromethamineKetorolac TromethamineAsclemed USA, Inc.ANDACurrent
80425-0139ToradolKetorolac 10mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0139Ketorolac TromethamineKetorolac TromethamineAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0139Ketorolac TromethamineKetorolac TromethamineAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42876ORIG1997-05-16