Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076201
Company: DEXCEL LTD
Company: DEXCEL LTD
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 | 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 |
---|---|---|---|---|---|---|---|
11/06/2002 | 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 |
---|---|---|---|---|---|
03/01/2024 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/28/2021 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/14/2014 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
07/31/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
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11/29/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
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03/13/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
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10/23/2003 | SUPPL-3 | Labeling |
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 | RICONPHARMA LLC |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075492 | VPNA |