Details for New Drug Application (NDA): 090912

NDA 090912 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 090912

Tradename:	ACARBOSE
Applicant:	Strides Pharma
Ingredient:	acarbose
Patents:	0

Pharmacology for NDA: 090912

Mechanism of Action

alpha Glucosidase Inhibitors

Medical Subject Heading (MeSH) Categories for 090912

Glycoside Hydrolase Inhibitors

Suppliers and Packaging for NDA: 090912

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACARBOSE	acarbose	TABLET;ORAL	090912	ANDA	A-S Medication Solutions	50090-4952	50090-4952-1	30 TABLET in 1 BOTTLE (50090-4952-1)
ACARBOSE	acarbose	TABLET;ORAL	090912	ANDA	Bryant Ranch Prepack	63629-5698	63629-5698-1	30 TABLET in 1 BOTTLE (63629-5698-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 27, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 27, 2011	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jul 27, 2011	TE:	AB	RLD:	No

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