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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204024
Company: SUN PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSAMPRENAVIR CALCIUM FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET;ORAL Prescription AB 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
11/20/2019 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/22/2025 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

FOSAMPRENAVIR CALCIUM

TABLET;ORAL; EQ 700MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOSAMPRENAVIR CALCIUM FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET;ORAL Prescription No AB 204060 MYLAN
FOSAMPRENAVIR CALCIUM FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET;ORAL Prescription No AB 204024 SUN PHARM
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