An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	SETON PHARMS
PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE	300MG/VIAL	FOR SOLUTION;INHALATION	Prescription	No	AN	206983	X-GEN PHARMS INC

Top