Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077105
Company: NOSTRUM LABS INC

Products on ANDA 077105

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 077105

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2005	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
04/21/2020	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/23/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/23/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/23/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/23/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/10/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/10/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/10/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/10/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.