Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076539
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALPROATE SODIUM VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
06/26/2003 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
10/11/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/22/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/22/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/22/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/22/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/22/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

VALPROATE SODIUM

INJECTABLE;INJECTION; EQ 100MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VALPROATE SODIUM VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076295 ATHENEX INC
VALPROATE SODIUM VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076539 FRESENIUS KABI USA
VALPROATE SODIUM VALPROATE SODIUM EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AP 078523 HIKMA FARMACEUTICA

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