Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203411
Company: SANDOZ

Products on ANDA 203411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEVIRAPINE	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203411Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2025	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/25/2022	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/29/2019	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/29/2019	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 203411

NEVIRAPINE

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEVIRAPINE	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206879	MACLEODS PHARMS LTD
NEVIRAPINE	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205651	MYLAN
NEVIRAPINE	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203411	SANDOZ