Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215787
Company: SENORES PHARMS
Company: SENORES PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | AB | No | No |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | TABLET;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 |
---|---|---|---|---|---|---|---|
03/15/2023 | 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 |
---|---|---|---|---|---|
11/09/2023 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
DICLOFENAC POTASSIUM
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CATAFLAM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 076561 | AMICI |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 215585 | NOVAST LABS |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075463 | RK PHARMA |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075229 | RUBICON |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 215787 | SENORES PHARMS |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 075219 | TEVA |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 215750 | UMEDICA |
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CATAFLAM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 076561 | AMICI |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 075229 | RUBICON |
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 215787 | SENORES PHARMS |