Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074761
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 10MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 05/16/1997 | 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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/20/2012 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/12/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1998 | 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 |