Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205651
Company: MYLAN

Products on ANDA 205651

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 205651

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2014	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2024	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2019	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2019	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205651

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