An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
VIRAMUNE	NEVIRAPINE	50MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AA	020933	BOEHRINGER INGELHEIM

Top