Drug Master Files for: THEOPHYLLINE
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THEOPHYLLINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18896 | I | II | 10/17/2005 | STANDARD CHEM AND PHARM CO LTD | THEOPHYLLINE SODIUM GLYCINATE |
| 1911 | I | II | 4/4/1972 | GANES CHEMICALS INC PENNSVILLE DIV | 8 - BROMOTHEOPHYLLINE |
| 20455 | A | II | 4/19/2007 | SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH | THEOPHYLLINE HYDROUS |
| 22481 | I | II | 2/6/2009 | CSPC INNOVATION PHARM CO LTD | THEOPHYLLINE |
| 23244 | I | II | 11/2/2009 | HAINAN POLY PHARMACEUTICAL CO LTD | THEOPHYLLINE EXTENDED RELEASE CAPSULES |
| 2730 | I | II | 8/27/1976 | CONCORD LABORATORIES INC | THEOPHYLLINE CAPS., 250MG |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
