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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213001
Company: GLAND PHARMA LTD

Products on ANDA 213001

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSCARNET SODIUM	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213001

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213001Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213001

FOSCARNET SODIUM

INJECTABLE;INJECTION; 2.4GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSCARNET SODIUM	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	213807	AVET LIFESCIENCES
FOSCARNET SODIUM	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212483	FRESENIUS KABI USA
FOSCARNET SODIUM	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	213001	GLAND PHARMA LTD
FOSCAVIR	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020068	CLINIGEN HLTHCARE

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