Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215375
Company: ANNORA PHARMA
Company: ANNORA PHARMA
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 |
---|---|---|---|---|---|---|---|
03/04/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
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 | PAR FORM |