Drug Master Files for: nebivolol hydrochloride
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nebivolol hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15417 | A | II | 5/7/2001 | JANSSEN PHARMACEUTICA NV | NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE AS |
| 21152 | A | II | 12/8/2007 | CADILA PHARMACEUTICALS LTD | Nebivolol Hydrochloride |
| 22735 | A | II | 3/31/2009 | FIS FABBRICA ITALIANA SINTETICI SPA | NEBIVOLOL HYDROCHLORIDE |
| 22906 | A | II | 6/29/2009 | TORRENT PHARMACEUTICALS LTD | NEBIVOLOL HYDROCHLORIDE |
| 24821 | I | II | 3/31/2011 | DR REDDYS LABORATORIES LTD | NEBIVOLOL HYDROCHLORIDE |
| 24916 | A | II | 5/4/2011 | MSN PHARMACHEM PRIVATE LTD | NEBIVOLOL HYDROCHLORIDE[ROUTE CODE: NH] |
| 25296 | A | II | 9/12/2011 | HETERO DRUGS LTD | NEBIVOLOL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
