Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076152
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| 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 |
|---|---|---|---|---|---|---|---|
| 12/13/2001 | 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 |
|---|---|---|---|---|---|
| 07/16/2026 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2024 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/12/2024 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2017 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2010 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/25/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/15/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/12/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
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 | 076152 | AUROBINDO PHARMA USA |
| 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 | INGENUS PHARMS LLC |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075492 | VPNA |