Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040342
Company: VISTAPHARM

Products on ANDA 040342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION;ORAL	Discontinued	None	No	No
PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40342ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/02/2021	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/02/2021	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/02/2021	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/02/2021	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/02/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/15/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/15/2014	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/15/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/26/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.