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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206983
Company: X-GEN PHARMS INC

Products on ANDA 206983

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206983

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206983

PENTAMIDINE ISETHIONATE

FOR SOLUTION;INHALATION; 300MG/VIAL
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEBUPENT	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	Yes	AN	019887	FRESENIUS KABI USA
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	No	AN	206667	PAI HOLDINGS
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	No	AN	206983	X-GEN PHARMS INC

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