Drug Master Files for: bupropion hydrochloride
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bupropion hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11054 | A | II | 8/30/1994 | ERREGIERRE SPA | BUPROPION HYDROCHLORIDE USP |
| 11196 | I | II | 11/14/1994 | NORDIC SYNTHESIS AB | BUPROPION HYDROCHLORIDE |
| 11834 | A | II | 1/29/1996 | CHEMI SPA | BUPROPION HYDROCHLORIDE |
| 12089 | I | II | 8/12/1996 | CILAG AG | BUPROPION HYDROCHLORIDE |
| 13851 | I | II | 11/16/1998 | SOLMAG SPA | BUPROPION HYDROCHLORIDE |
| 13927 | A | II | 12/21/1998 | OLON SPA | BUPROPION HYDROCHLORIDE |
| 14534 | A | II | 11/11/1999 | DIPHARMA FRANCIS SRL | BUPROPION HCL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
