Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077702
Company: AUROBINDO

Products on ANDA 077702

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEVIRAPINE	NEVIRAPINE	50MG/5ML	SUSPENSION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077702

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/2005/077702TA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2022	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/21/2019	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2019	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/16/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/04/2013	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077702

NEVIRAPINE

SUSPENSION;ORAL; 50MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEVIRAPINE	NEVIRAPINE	50MG/5ML	SUSPENSION;ORAL	Prescription	No	AA	077702	AUROBINDO
NEVIRAPINE	NEVIRAPINE	50MG/5ML	SUSPENSION;ORAL	Prescription	No	AA	207684	CIPLA
VIRAMUNE	NEVIRAPINE	50MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AA	020933	BOEHRINGER INGELHEIM