Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216275
Company: RICONPHARMA LLC
Company: RICONPHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/23/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DICLOFENAC SODIUM
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076201 | DEXCEL LTD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216275 | RICONPHARMA LLC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075492 | VPNA |