Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090066
Company: UNIQUE
Company: UNIQUE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | Yes |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/01/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
03/29/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/22/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
10/15/2014 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
DICLOFENAC SODIUM
TABLET, DELAYED RELEASE;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075185 | CARLSBAD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 216548 | RUBICON |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090066 | UNIQUE |
TABLET, DELAYED RELEASE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 074514 | ACTAVIS ELIZABETH |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075185 | CARLSBAD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 216548 | RUBICON |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090066 | UNIQUE |