Drug Master Files for: LURASIDONE HYDROCHLORIDE
✉ Email this page to a colleague
LURASIDONE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 26700 | A | II | 3/22/2013 | DR REDDYS LABORATORIES LTD | LURASIDONE HYDROCHLORIDE |
| 27452 | A | II | 9/20/2013 | GLENMARK PHARMACEUTICALS LTD | LURASIDONE HYDROCHLORIDE |
| 27570 | A | II | 9/30/2013 | MSN PHARMACHEM PRIVATE LTD | LURASIDONE HYDROCHLORIDE [ROUTE CODE - LN] |
| 27584 | A | II | 12/5/2013 | ALP PHARM BEIJING CO LTD | LURASIDONE HYDROCHLORIDE |
| 27898 | A | II | 4/30/2014 | AMSA SPA | LURASIDONE HYDROCHLORIDE |
| 27963 | A | II | 4/11/2014 | LUPIN LTD | LURASIDONE HYDROCHLORIDE |
| 27970 | A | II | 2/20/2014 | HETERO DRUGS LTD | LURASIDONE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
