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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091343

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NDA 091343 describes ACARBOSE, which is a drug marketed by Emcure Pharms Ltd, Impax Labs, Mylan, Strides Pharma, Virtus Pharm, Watson Labs, and West-ward Pharms Int, and is included in seven NDAs. It is available from ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the acarbose profile page.

Summary for 091343

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 091343

Mechanism of Actionalpha Glucosidase Inhibitors

Medical Subject Heading (MeSH) Categories for 091343

Suppliers and Packaging for NDA: 091343

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACARBOSE acarbose TABLET;ORAL 091343 ANDA AvKARE, Inc. 42291-130 42291-130-90 90 TABLET in 1 BOTTLE (42291-130-90)
ACARBOSE acarbose TABLET;ORAL 091343 ANDA AvKARE, Inc. 42291-131 42291-131-90 90 TABLET in 1 BOTTLE (42291-131-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Oct 17, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 17, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 17, 2013TE:ABRLD:No


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