Drugs@FDA: FDA-Approved Drugs
Company: BIONPHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
06/29/1993 | 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 |
---|---|---|---|---|---|
01/14/2022 | SUPPL-42 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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01/14/2022 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/09/2019 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/09/2019 | SUPPL-37 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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12/09/2019 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2019 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/09/2019 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2015 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2015 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2015 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
12/10/2014 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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12/10/2014 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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12/10/2014 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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12/10/2014 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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01/25/2011 | SUPPL-20 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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01/12/2010 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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04/01/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
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09/23/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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12/17/2006 | SUPPL-13 | Labeling |
Label is not available on this site. |
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10/08/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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08/02/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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08/02/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/02/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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01/30/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
VALPROIC ACID
CAPSULE;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 073484 | BIONPHARMA |
VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 073229 | CATALENT |