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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009395
Company: GLENWOOD

Products on NDA 009395

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PASKALIUM	POTASSIUM AMINOSALICYLATE	1GM	TABLET;ORAL	Discontinued	None	No	No
PASKALIUM	POTASSIUM AMINOSALICYLATE	500MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009395

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/1955	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

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