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Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 204024

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204024

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.

Therapeutic Equivalents for ANDA 204024

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
LEXIVA	FOSAMPRENAVIR CALCIUM	EQ 700MG BASE	TABLET;ORAL	Prescription	Yes	AB	021548	VIIV HLTHCARE

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