Drug Master Files for: MOXIFLOXACIN HYDROCHLORIDE
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MOXIFLOXACIN HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16999 | A | II | 12/2/2003 | DR REDDYS LABORATORIES LTD | MOXIFLOXACIN HYDROCHLORIDE USP |
| 17000 | I | II | 12/3/2003 | MYLAN LABORATORIES LTD | MOXIFLOXACIN HYDROCHLORIDE |
| 18789 | A | II | 9/19/2005 | NEULAND LABORATORIES LTD | MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE USP |
| 20170 | I | II | 7/31/2008 | CIPLA LTD | MOXIFLOXACIN HYDROCHLORIDE PH. EUR. |
| 20755 | A | II | 8/3/2007 | MSN PHARMACHEM PRIVATE LTD | MOXIFLOXACIN HYDROCHLORIDE USP (MONOHYDRATE) [ROUTE CODE - MM] |
| 23315 | I | II | 11/27/2009 | ITF CHEMICAL LTDA | MOXIFLOXACIN HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
