Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075379
Company: PHARM ASSOC
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 |
|---|---|---|---|---|---|
| 02/21/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 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 |