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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206666
Company: SETON PHARMS

Products on ANDA 206666

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206666

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206666

PENTAMIDINE ISETHIONATE

INJECTABLE;INJECTION; 300MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PENTAM	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	019264	FRESENIUS KABI USA
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	213806	AVET LIFESCIENCES
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206666	SETON PHARMS
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206982	XGEN PHARMS

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