Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 08/25/1992 | 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 |
|---|---|---|---|---|---|
| 10/30/2020 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/30/2020 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2020 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/06/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/23/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/05/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/2001 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/02/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/26/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/11/2000 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1995 | SUPPL-1 | Manufacturing (CMC) |
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 |