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): 216168
Company: ANNORA PHARMA

Products on ANDA 216168

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	800MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2025	ORIG-2	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216168Orig1s000ltr;216168Orig1s000TALtr.pdf
01/21/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216168Orig1s000ltr;216168Orig1s000TALtr.pdf

Therapeutic Equivalents for ANDA 216168

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	216168	ANNORA PHARMA
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	202136	MYLAN
DARUNAVIR	DARUNAVIR	600MG	TABLET;ORAL	Prescription	No	AB	214085	ZYDUS LIFESCIENCES
PREZISTA	DARUNAVIR	600MG	TABLET;ORAL	Prescription	Yes	AB	021976	JANSSEN PRODS

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DARUNAVIR	DARUNAVIR	800MG	TABLET;ORAL	Prescription	No	AB	212493	AMNEAL
DARUNAVIR	DARUNAVIR	800MG	TABLET;ORAL	Prescription	No	AB	216168	ANNORA PHARMA
DARUNAVIR	DARUNAVIR	800MG	TABLET;ORAL	Prescription	No	AB	210677	AUROBINDO PHARMA LTD
DARUNAVIR	DARUNAVIR	800MG	TABLET;ORAL	Prescription	No	AB	206288	CIPLA
DARUNAVIR	DARUNAVIR	800MG	TABLET;ORAL	Prescription	No	AB	211578	DR REDDYS
DARUNAVIR	DARUNAVIR	800MG	TABLET;ORAL	Prescription	No	AB	202073	LUPIN LTD
DARUNAVIR	DARUNAVIR	800MG	TABLET;ORAL	Prescription	No	AB	215389	MSN
DARUNAVIR	DARUNAVIR	800MG	TABLET;ORAL	Prescription	No	AB	214085	ZYDUS LIFESCIENCES
PREZISTA	DARUNAVIR	800MG	TABLET;ORAL	Prescription	Yes	AB	021976	JANSSEN PRODS

Top