Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED 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 |
---|---|---|---|---|---|---|---|
03/26/1996 | 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 |
---|---|---|---|---|---|
07/11/2024 | SUPPL-46 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/28/2021 | SUPPL-44 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/31/2021 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/09/2016 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/07/2014 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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05/11/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
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05/08/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
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07/28/2006 | SUPPL-16 | Labeling |
Label is not available on this site. |
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07/01/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
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02/20/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
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02/21/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/02/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/13/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/16/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/04/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/02/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/12/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DICLOFENAC SODIUM
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 |
TABLET, DELAYED RELEASE;ORAL; 75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 074514 | ACTAVIS ELIZABETH |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075185 | CARLSBAD |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 216548 | RUBICON |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077863 | UNIQUE |