Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075492
Company: VPNA
Company: VPNA
| 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 |
|---|---|---|---|---|---|---|---|
| 02/11/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75492ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75492_Doclofenac.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/29/2021 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/26/2021 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/30/2010 | SUPPL-6 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/08/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/14/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/2001 | 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 | 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 |