Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090517
Company: PHARMA LIFE
Company: PHARMA LIFE
| 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 |
|---|---|---|---|---|---|---|---|
| 05/28/2010 | 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 |
|---|---|---|---|---|---|
| 01/16/2015 | SUPPL-2 | Labeling-Container/Carton Labels, 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 | 074060 | HIGH TECH PHARMA |
| VALPROIC ACID | VALPROIC ACID | 250MG/5ML | SYRUP;ORAL | Prescription | No | AA | 077960 | LANNETT CO INC |
| 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 | PHARMA LIFE |
| VALPROIC ACID | VALPROIC ACID | 250MG/5ML | SYRUP;ORAL | Prescription | No | AA | 070868 | WOCKHARDT BIO AG |
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