Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
01/27/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74993ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/04/2024 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
11/21/2022 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
04/28/2021 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
05/20/2016 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
05/29/2013 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
04/30/2012 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
03/14/2003 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
07/03/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
02/14/2001 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
12/04/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/04/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
KETOROLAC TROMETHAMINE
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 |