Drug Master Files for: AMOXICILLIN
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AMOXICILLIN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11451 | I | II | 4/14/1995 | CONSOLIDATED PHARMACEUTICAL GROUP INC | AMOXICILLIN TRIHYDRATE BPC |
| 11481 | I | II | 4/28/1995 | CONSOLIDATED PHARMACEUTICAL GROUP INC | AMOXICILLIN TRIHYDRATE CAPSULES |
| 11483 | I | II | 4/28/1995 | CONSOLIDATED PHARMACEUTICAL GROUP INC | AMOXICILLIN TRIHYDRATE FOR ORAL SUSPENSION |
| 12895 | I | II | 3/11/1998 | SUN PHARMACEUTICAL INDUSTRIES LTD | AMOXICILLIN USP, TRIHYDRATE, (NON-STERILE BULK) |
| 12904 | I | II | 3/18/1998 | TORRENT GUJARAT BIOTECH LTD | AMOXICILLIN, USP |
| 13201 | I | II | 4/30/1998 | SMITHKLINE BEECHAM | AMOXICILLIN TRIHYDRATE |
| 13207 | A | II | 4/30/1998 | GLAXOSMITHKLINE LLC | AMOXICILLIN TRIHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
