Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202964
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 05/02/2016 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202964Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202964Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2023 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/09/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/09/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/02/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202964Orig1s000lbl.pdf |
DICLOFENAC POTASSIUM
FOR SOLUTION;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAMBIA | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;ORAL | Prescription | Yes | AB | 022165 | ASSERTIO |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;ORAL | Prescription | No | AB | 216635 | ALKEM LABS LTD |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;ORAL | Prescription | No | AB | 215375 | ANNORA PHARMA |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;ORAL | Prescription | No | AB | 202964 | ENDO OPERATIONS |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | FOR SOLUTION;ORAL | Prescription | No | AB | 218011 | TARO |