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Generated: October 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078470

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NDA 078470 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 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. Twelve suppliers are listed for this compound. Additional details are available on the acarbose profile page.
Summary for 078470
Tradename:ACARBOSE
Applicant:West-ward Pharms Int
Ingredient:acarbose
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078470
Mechanism of Actionalpha Glucosidase Inhibitors
Medical Subject Heading (MeSH) Categories for 078470
Suppliers and Packaging for NDA: 078470
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACARBOSE acarbose TABLET;ORAL 078470 ANDA West-Ward Pharmaceuticals Corp 0054-0140 0054-0140-25 100 TABLET in 1 BOTTLE (0054-0140-25)
ACARBOSE acarbose TABLET;ORAL 078470 ANDA West-Ward Pharmaceuticals Corp 0054-0141 0054-0141-20 10 BLISTER PACK in 1 CARTON (0054-0141-20) > 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 7, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 7, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 7, 2008TE:ABRLD:No

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