Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210616
Company: CHARTWELL RX
Company: CHARTWELL RX
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 |
---|---|---|---|---|---|---|---|
08/16/2018 | ORIG-1 | Approval | STANDARD |
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-1 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
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 |