Drug Master Files for: ivabradine hydrochloride
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ivabradine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27979 | A | II | 3/14/2014 | ORIL INDUSTRIE | IVABRADINE HYDROCHLORIDE |
| 28658 | A | II | 9/29/2014 | BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTD | IVABRADINE HYDROCHLORIDE |
| 32074 | A | II | 9/30/2017 | ALEMBIC PHARMACEUTICALS LTD | IVABRADINE HYDROCHLORIDE |
| 32420 | A | II | 2/7/2018 | JIANGSU HENGRUI MEDICINE CO LTD | IVABRADINE MONOSULFATE |
| 33077 | A | II | 9/21/2018 | BIONPHARMA INC | IVABRADINE HYDROCHLORIDE |
| 33107 | A | II | 10/31/2018 | CADILA HEALTHCARE LTD | IVABRADINE HYDROCHLORIDE |
| 33213 | A | II | 10/15/2018 | URQUIMA SA | IVABRADINE HYDROCHLORIDE (FORM IV) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
