Last Updated: September 25, 2026

Details for New Drug Application (NDA): 080138

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NDA 080138 describes SODIUM P.A.S., which is a drug marketed by Lannett and is included in one NDA. Additional details are available on the SODIUM P.A.S. profile page.

The generic ingredient in SODIUM P.A.S. is aminosalicylate sodium. There is one drug master file entry for this compound. Additional details are available on the aminosalicylate sodium profile page.

Summary for 080138

Tradename:	SODIUM P.A.S.
Applicant:	Lannett
Ingredient:	aminosalicylate sodium
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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