Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084349
Company: VIATRIS

• Medication Guide

Products on ANDA 84349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILANTIN	PHENYTOIN SODIUM	30MG EXTENDED	CAPSULE;ORAL	Prescription	None	Yes	Yes
DILANTIN	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Labels for ANDA 084349

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/07/2022	SUPPL-88	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/084349s088lbl.pdf
10/22/2021	SUPPL-87	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/084349s087lbl.pdf
08/07/2020	SUPPL-86	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/084349s086lbl.pdf
12/03/2018	SUPPL-85	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/084349s085lbl.pdf
12/22/2017	SUPPL-84	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
12/22/2017	SUPPL-82	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
12/22/2017	SUPPL-81	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf
02/01/2017	SUPPL-80	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s080lbl.pdf
04/16/2015	SUPPL-74	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/084349Orig1s074lbl.pdf
07/03/2014	SUPPL-73	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s073lbl.pdf
02/27/2014	SUPPL-72	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf
02/27/2014	SUPPL-62	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/084349Orig1s062s072lbl.pdf
08/06/2013	SUPPL-70	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/084349Orig1s070lbl.pdf
11/27/2012	SUPPL-67	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/084349s067lbl.pdf
04/08/2011	SUPPL-64	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/084349s064,084427s023lbl.pdf
05/06/2009	SUPPL-60	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf
05/06/2009	SUPPL-60	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/084349s060lbl.pdf