Drug Master Files for: Qilu Tianhe
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Qilu Tianhe Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
18883 | I | II | 10/18/2005 | QILU TIANHE PHARMACEUTICAL CO LTD | TAZOBACTAM ACID (INTERMEDIATE, NON-STERILE BULK) |
20428 | A | II | 4/5/2007 | QILU TIANHE PHARMACEUTICAL CO LTD | TAZOBACTAM ACID (PROCESS I, NON-STERILE BULK) |
20432 | A | II | 4/9/2007 | QILU TIANHE PHARMACEUTICAL CO LTD | STERILE PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) |
20615 | A | II | 6/15/2007 | QILU TIANHE PHARMACEUTICAL CO LTD | HYDROXYUREA USP (NON-STERILE BULK) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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