Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204648
Company: BIONPHARMA INC
Company: BIONPHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 02/23/2016 | 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 |
|---|---|---|---|---|---|
| 03/02/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DICLOFENAC POTASSIUM
CAPSULE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | CAPSULE;ORAL | Prescription | No | AB | 204648 | BIONPHARMA INC |
| ZIPSOR | DICLOFENAC POTASSIUM | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 022202 | ASSERTIO |
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