Drug Master Files for: HYDRALAZINE HYDROCHLORIDE
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HYDRALAZINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1909 | I | II | 3/27/1972 | ALLIED CHEMICAL CORP | HYDRALAZINE HCL |
| 19209 | I | II | 2/10/2006 | SHANDONG WEIFANG PHARMACEUTICAL FACTORY CO LTD | HYDRALAZINE HYDROCHLORIDE (NON-STERILE A PHARMACEUTICAL INGREDIENT) |
| 19904 | A | II | 10/26/2006 | NAVINTA LLC | HYDRALAZINE HYDROCHLORIDE USP |
| 20520 | A | II | 5/9/2007 | HETERO LABS LTD | HYDRALAZINE HYDROCHLORIDE |
| 21953 | I | II | 9/5/2008 | DK PHARMA CHEM PVT LTD | HYDRALAZINE HYDROCHLORIDE USP |
| 22169 | A | II | 10/31/2008 | EUTICALS SPA | HYDRALAZINE HYDROCHLORIDE |
| 22633 | A | II | 3/16/2009 | SOLARA A PHARMA SCIENCES LTD | HYDRALAZINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
