Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090688
Company: MACLEODS PHARMS LTD

Products on ANDA 090688

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090688

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2019	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090688s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2023	SUPPL-17	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090688

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