Drug Master Files for: ACARBOSE
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ACARBOSE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18138 | A | II | 2/24/2005 | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | ACARBOSE |
| 19069 | A | II | 12/14/2005 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | ACARBOSE USP |
| 20759 | A | II | 7/31/2007 | CKD BIO CORP | ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE |
| 23279 | I | II | 11/18/2009 | LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTD | ACARBOSE |
| 25207 | A | II | 7/11/2011 | HEBEI HUARONG PHARMACEUTICAL CO LTD | ACARBOSE |
| 8539 | A | II | 4/23/1990 | BAYER AG | ACARBOSE |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
