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Details for New Drug Application (NDA): 012715

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NDA 012715 describes GANTANOL-DS, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the GANTANOL-DS profile page.

The generic ingredient in GANTANOL-DS is sulfamethoxazole. There are twenty-six drug master file entries for this compound. Additional details are available on the sulfamethoxazole profile page.

Summary for NDA: 012715

Tradename:
GANTANOL
Applicant:
Roche
Ingredient:
sulfamethoxazole
Patents:0
Formulation / Manufacturing:see details

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1GM
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.

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