Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091037
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
DEPAKENE VALPROIC ACID 250MG CAPSULE;ORAL Prescription Yes AB 018081 ABBVIE
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 207611 NOVELGENIX THERAPS
VALPROIC ACID VALPROIC ACID 250MG CAPSULE;ORAL Prescription No AB 091037 SUN PHARM INDS LTD

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