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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078441

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NDA 078441 describes ACARBOSE, which is a drug marketed by Avet Lifesciences, Dash Pharms, Hangzhou Zhongmei, Hikma, Impax Labs, Somerset Theraps Llc, Strides Pharma, and Watson Labs, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the ACARBOSE profile page.

The generic ingredient in ACARBOSE is acarbose. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the acarbose profile page.

Summary for 078441

Tradename:	ACARBOSE
Applicant:	Impax Labs
Ingredient:	acarbose
Patents:	0

Medical Subject Heading (MeSH) Categories for 078441

Glycoside Hydrolase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 14, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 14, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	May 14, 2009	TE:	AB	RLD:	No

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