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FDA Approval

Acarbose

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 12, 2009
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Acarbose(25 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acarbose

Product Details

NDC Product Code
54868-5945
Application Number
ANDA078470
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 9, 2010
AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 25 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
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