Drug Master Files for: ACEBUTOLOL HYDROCHLORIDE
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ACEBUTOLOL HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14420 | A | II | 9/22/1999 | MOEHS IBERICA SL | ACEBUTOLOL |
| 4141 | I | II | 3/24/1981 | MAY AND BAKER LTD | ACEBUTOLOL HCL/SECTRAL |
| 7990 | I | II | 3/28/1989 | ERREGIERRE SPA | ACEBUTOLOL HYDROCHLORIDE |
| 8874 | I | II | 12/4/1990 | QUIMICA SINTETICA SA | ACEBUTOLOL HYDROCHLORIDE |
| 9376 | A | II | 10/9/1991 | CAMBREX PROFARMACO MILANO SRL | ACEBUTOLOL HYDROCHLORIDE |
| 9382 | I | II | 10/23/1991 | SANOFI CHIMIE | ACEBUTOLOL HYDROCHLORIDE |
| 9442 | I | II | 11/27/1991 | LUSOCHIMICA SPA | ACEBUTOLOL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
