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Drugs@FDA: FDA-Approved Drugs

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

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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