Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090517
Company: QUAGEN

Products on ANDA 090517

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090517

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
04/17/2026	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/16/2015	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090517

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