Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090517
Company: ECI PHARMS LLC

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 090517 ECI PHARMS LLC
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 075782 VISTAPHARM
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription No AA 070868 WOCKHARDT BIO AG

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