Viewing data from:

ACARBOSE

ANDA

ACARBOSE | A078470 | HIKMA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs2 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGACARBOSE

DMF 85391990

ZHEJIANG HISUN PHARMACEUTICAL CO LTDACARBOSE USP

DMF 190692005

HEBEI HUARONG PHARMACEUTICAL CO LTDACARBOSE

DMF 252072011

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTDACARBOSE

DMF 351882020

CSPC SHENGXUE GLUCOSE CO LTDACARBOSE

DMF 356032021

HANGZHOU ZHONGMEIHUADONG PHARMACEUTICAL JIANGDONG CO LTDACARBOSE USP

DMF 371452022

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDInactiveACARBOSE

DMF 181382005

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveACARBOSE

DMF 232792009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 9, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 7, 2008

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 7, 2008

#003 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 7, 2008