Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091037
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 02/22/2013 | 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 |
|---|---|---|---|---|---|
| 12/15/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2014 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
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 INC |
| VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 073229 | CATALENT |
| VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 091037 | SUN PHARM INDS LTD |
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