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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077960
Company: LANNETT CO INC

Products on ANDA 077960

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077960

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
10/14/2020	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/14/2020	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/14/2020	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/14/2020	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/14/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/28/2016	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
04/28/2016	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Medication Guide		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-Medication Guide, Labeling-Package Insert		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.

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