Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075772
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 60MG/2ML | INJECTABLE; INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/21/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/21/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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09/21/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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04/28/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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01/28/2019 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/09/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION; 15MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214456 | ALEMBIC |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217166 | ASPIRO |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209900 | BAXTER HLTHCARE CORP |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217789 | CAPLIN |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075784 | FRESENIUS KABI USA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203242 | FRESENIUS KABI USA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204216 | GLAND |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075772 | HIKMA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074802 | HOSPIRA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091065 | SAGENT PHARMS INC |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078737 | SUN PHARM |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077942 | WOCKHARDT |
INJECTABLE;INJECTION; 30MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214456 | ALEMBIC |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217166 | ASPIRO |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209900 | BAXTER HLTHCARE CORP |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217789 | CAPLIN |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075784 | FRESENIUS KABI USA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203242 | FRESENIUS KABI USA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204216 | GLAND |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075772 | HIKMA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074802 | HOSPIRA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074993 | HOSPIRA |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211445 | NEPHRON |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091065 | SAGENT PHARMS INC |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076271 | SANDOZ |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078737 | SUN PHARM |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077942 | WOCKHARDT |