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Details for New Drug Application (NDA): 091053

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NDA 091053 describes ACARBOSE, which is a drug marketed by Strides Pharma, Watson Labs, Impax Labs, Virtus Pharm, Mylan, Roxane, and Emcure Pharms Ltd, and is included in seven NDAs. It is available from eleven 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. Fourteen suppliers are listed for this compound. Additional details are available on the acarbose profile page.

Summary for NDA: 091053

Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 091053

Mechanism of Actionalpha Glucosidase Inhibitors

Suppliers and Packaging for NDA: 091053

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 091053 ANDA Mylan Pharmaceuticals Inc. 0378-2820 0378-2820-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-2820-77)
TABLET;ORAL 091053 ANDA Mylan Pharmaceuticals Inc. 0378-2821 0378-2821-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-2821-77)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 6, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 6, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 6, 2011TE:ABRLD:No

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