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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202118
Company: TEVA PHARMS USA

Products on ANDA 202118

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	AB	No	No
DARUNAVIR	DARUNAVIR	150MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
DARUNAVIR	DARUNAVIR	400MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2017	ORIG-2	Tentative Approval	Not Applicable			Label is not available on this site.
11/21/2017	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202118Orig1s000ApprovandTAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/21/2023	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202118

DARUNAVIR

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	212493	AMNEAL
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	210677	AUROBINDO PHARMA LTD
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	206288	CIPLA
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	211578	DR REDDYS
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	202083	HETERO LABS LTD III
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	202073	LUPIN LTD
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	215389	MSN
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	202118	TEVA PHARMS USA
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	214085	ZYDUS LIFESCIENCES
PREZISTA	DARUNAVIR	600MG	TABLET;ORAL	Prescription	Yes	AB	021976	JANSSEN PRODS

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