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Details for New Drug Application (NDA): 090912

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NDA 090912 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: 090912

Tradename:
ACARBOSE
Applicant:
Strides Pharma
Ingredient:
acarbose
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 090912

Mechanism of Actionalpha Glucosidase 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 Libertas Pharma, Inc. 51862-210 51862-210-01 100 TABLET in 1 BOTTLE, PLASTIC (51862-210-01)
ACARBOSE
acarbose
TABLET;ORAL 090912 ANDA Libertas Pharma, Inc. 51862-211 51862-211-01 100 TABLET in 1 BOTTLE, PLASTIC (51862-211-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 27, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 27, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 27, 2011TE:ABRLD:No


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