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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207684
Company: CIPLA

Products on ANDA 207684

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 207684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2017	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
12/21/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207684

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

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