Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075782
Company: CHARTWELL RX
Company: CHARTWELL RX
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 |
---|---|---|---|---|---|---|---|
12/22/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75782ltr.pdf |
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 |