Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074754
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 05/16/1997 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/74754_Ketorolac.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/06/2022 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/20/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/06/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
KETOROLAC TROMETHAMINE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 216407 | ATNAHS PHARMA US |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 216759 | BIONPHARMA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 210616 | CHARTWELL RX |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 216651 | HETERO LABS LTD III |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 215745 | LEADING |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 074761 | MYLAN |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 215788 | SENORES PHARMS |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 074754 | TEVA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | No | AB | 217038 | ZYDUS LIFESCIENCES |