Drug Master Files for: bendamustine hydrochloride
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bendamustine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22626 | A | II | 3/13/2009 | CHEMPACIFIC CORP | BENDAMUSTINE HYDROCHLORIDE |
| 24823 | A | II | 3/30/2011 | DR REDDYS LABORATORIES LTD | BENDAMUSTINE HYDROCHLORIDE |
| 25222 | A | II | 11/8/2011 | SHILPA MEDICARE LTD | BENDAMUSTINE HCL |
| 25394 | I | II | 10/18/2011 | EUTICALS SPA | BENDAMUSTINE HYDROCHLORIDE HYDRATE |
| 25512 | A | II | 11/18/2011 | HERAEUS DEUTSCHLAND GMBH AND CO KG | BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE |
| 25524 | A | II | 11/24/2011 | CHONGQING HUAPONT PHARMACEUTICAL CO LTD | BENDAMUSTINE HCL |
| 25800 | A | II | 2/21/2012 | HETERO LABS LTD | BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
