Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077960
Company: LANNETT CO INC
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
10/13/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077960s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2016 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

04/28/2016 SUPPL-18 Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

04/28/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/28/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

04/28/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

04/28/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/15/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/15/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/15/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/15/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/15/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/15/2014 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/20/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/07/2007 SUPPL-1 Labeling

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 073178 ANI PHARMS INC
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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