Drug Master Files for: quinine sulfate
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quinine sulfate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17086 | A | II | 1/5/2004 | BUCHLER GMBH | QUININE SULFATE, USP |
| 19905 | I | II | 10/24/2006 | PT SINKONA INDONESIA LESTARI | QUININE SULFATE USP |
| 20951 | I | II | 9/3/2007 | PT KIMIA FARMA PERSERO TBK | QUININE SULFATE |
| 20952 | I | II | 9/3/2007 | PT KIMIA FARMA PERSERO TBK | QUININE HYDROCHLORIDE |
| 23415 | I | II | 12/15/2009 | AANJANEYA LIFECARE LTD | QUININE SULPHATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
