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Details for New Drug Application (NDA): 009395

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NDA 009395 describes PASKALIUM, which is a drug marketed by Glenwood and is included in one NDA. Additional details are available on the PASKALIUM profile page.

The generic ingredient in PASKALIUM is potassium aminosalicylate. There are two hundred and twenty-one drug master file entries for this compound. Additional details are available on the potassium aminosalicylate profile page.

Summary for NDA: 009395

potassium aminosalicylate
Formulation / Manufacturing:see details

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1GM
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.