Drug Master Files for: hydroxychloroquine sulfate
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hydroxychloroquine sulfate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12762 | I | II | 11/12/1997 | ALKALOIDA CHEMICAL CO LTD | HYDROXYCHLOROQUINE SULFATE |
| 14087 | A | II | 4/17/1999 | IPCA LABORATORIES LTD | HYDROXYCHLOROQUINE SULFATE USP |
| 14977 | A | II | 8/1/2000 | CADILA HEALTHCARE LTD | HYDROXYCHLOROQUINE SULFATE USP |
| 20692 | A | II | 7/17/2007 | CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD | HYDROXYCHLOROQUINE SULFATE |
| 21115 | I | II | 2/6/2008 | WUHAN WUYAO PHARMACEUTICAL CO LTD | HYDROXYCHLOROQUINE SULFATE USP, NON-STERILE, BULK DRUG |
| 21567 | A | II | 4/25/2008 | AMRI RENSSELAER INC | HYDROXYCHLOROQUINE SULFATE, USP DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
