Drugs@FDA: FDA-Approved Drugs
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALPROIC ACID | VALPROIC ACID | 250MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
12/15/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75379ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/08/2024 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/08/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
02/21/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2015 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/13/2015 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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08/13/2015 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
03/15/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
VALPROIC ACID
SYRUP;ORAL; 250MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALPROIC ACID | VALPROIC ACID | 250MG/5ML | SYRUP;ORAL | Prescription | No | AA | 073178 | ANI PHARMS |
VALPROIC ACID | VALPROIC ACID | 250MG/5ML | SYRUP;ORAL | Prescription | No | AA | 075782 | CHARTWELL RX |
VALPROIC ACID | VALPROIC ACID | 250MG/5ML | SYRUP;ORAL | Prescription | No | AA | 075379 | PHARM ASSOC |
VALPROIC ACID | VALPROIC ACID | 250MG/5ML | SYRUP;ORAL | Prescription | No | AA | 090517 | QUAGEN |