Drug Master Files for: buspirone hydrochloride
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buspirone hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10414 | I | II | 8/9/1993 | ARCHIMICA SPA | BUSPIRONE HYDROCHLORIDE |
| 11148 | A | II | 10/21/1994 | FERMION OY | BUSPIRONE HYDROCHLORIDE |
| 11469 | I | II | 4/12/1995 | MEDICHEM SA | BUSPIRONE HYDROCHLORIDE |
| 12135 | I | II | 9/16/1996 | ALKALOIDA CHEMICAL CO ZRT | BUSPIRONE BASE |
| 12172 | I | II | 10/16/1996 | ALKALOIDA CHEMICAL CO ZRT | BUSPIRONE HYDROCHLORIDE |
| 12350 | I | II | 2/3/1997 | EGIS PHARMACEUTICALS PRIVATE LTD | BUSPIRONE HYDROCHLORIDE USP BULK |
| 12684 | I | II | 9/30/1997 | INDUSTRIALE CHIMICA SRL | BUSPIRONE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
