Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074802
Company: HOSPIRA
Company: HOSPIRA
| 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 | Yes |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/05/1997 | 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 |
|---|---|---|---|---|---|
| 03/04/2024 | SUPPL-56 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/15/2022 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2014 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/074802s038lbl.pdf | |
| 05/29/2013 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2003 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/04/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/06/2001 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/25/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/10/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1999 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/10/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1999 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/08/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/12/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/14/2014 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/074802s038lbl.pdf |
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 |