Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213875
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
10/19/2021 | ORIG-1 | Approval | STANDARD |
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 | 213875 | AUROBINDO PHARMA LTD |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | CAPSULE;ORAL | Prescription | No | AB | 204648 | BIONPHARMA |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210078 | STRIDES PHARMA |
ZIPSOR | DICLOFENAC POTASSIUM | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 022202 | ASSERTIO |