Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202523
Company: MYLAN PHARMS INC

Products on ANDA 202523

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEVIRAPINE	NEVIRAPINE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202523

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/22/2012	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
03/21/2024	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/21/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/21/2024	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/21/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202523

NEVIRAPINE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEVIRAPINE	NEVIRAPINE	200MG	TABLET;ORAL	Prescription	No	AB	077521	AUROBINDO
NEVIRAPINE	NEVIRAPINE	200MG	TABLET;ORAL	Prescription	No	AB	077956	CIPLA
NEVIRAPINE	NEVIRAPINE	200MG	TABLET;ORAL	Prescription	No	AB	078584	HETERO LABS LTD III
NEVIRAPINE	NEVIRAPINE	200MG	TABLET;ORAL	Prescription	No	AB	090688	MACLEODS PHARMS LTD
NEVIRAPINE	NEVIRAPINE	200MG	TABLET;ORAL	Prescription	No	AB	203080	MICRO LABS LTD
NEVIRAPINE	NEVIRAPINE	200MG	TABLET;ORAL	Prescription	No	AB	202523	MYLAN PHARMS INC
NEVIRAPINE	NEVIRAPINE	200MG	TABLET;ORAL	Prescription	No	AB	078195	STRIDES PHARMA