Drug Master Files for: balsalazide disodium
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balsalazide disodium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12287 | I | II | 12/20/1996 | SA AJINOMOTO OMNICHEM NV | BALSALAZIDE DISODIUM |
| 12289 | I | II | 12/18/1996 | COURTAULDS CHEMICALS | BALSALAZIDE DISODIUM |
| 16256 | I | II | 1/2/2003 | SA AJINOMOTO OMNICHEM NV | BALSALAZIDE DISODIUM |
| 16425 | A | II | 2/17/2003 | PHARMAZELL GMBH | BALSALAZIDE DISODIUM |
| 17326 | A | II | 4/19/2004 | FORMOSA LABORATORIES INC | BALSALAZIDE DISODIUM DIHYDRATE USP |
| 17500 | I | II | 6/25/2004 | FARCHEMIA SRL | BALSALAZIDE DISODIUM DIHYDRATE |
| 17780 | I | II | 10/20/2004 | IPCA LABORATORIES LTD | BALSALAZIDE DISODIUM DIHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
