Drug Master Files for: rilpivirine hydrochloride
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rilpivirine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23824 | A | II | 7/19/2010 | JANSSEN PHARMACEUTICA NV | RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE |
| 26305 | A | II | 8/3/2012 | SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD | RILPIVIRINE HYDROCHLORIDE |
| 27253 | A | II | 7/24/2013 | MYLAN LABORATORIES LTD | RILPIVIRINE HYDROCHLORIDE |
| 29301 | A | II | 4/16/2015 | HETERO DRUGS LTD | RILPIVIRINE HYDROCHLORIDE |
| 29841 | A | II | 12/8/2015 | LAURUS LABS LTD | RILPIVIRINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
