Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078584
Company: HETERO LABS LTD III

Products on ANDA 078584

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 078584

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			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078584taltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2024	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/24/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/24/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/20/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/14/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078584

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