Drug Master Files for: penicillin g benzathine
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penicillin g benzathine Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10179 | I | II | 6/8/1989 | GLAXOCHEM LTD | PENICILLIN G INTERMEDIATES |
10180 | I | II | 12/6/1983 | ACS DOBFAR UK LTD | PENICILLIN G INTERMEDIATES |
10234 | I | II | 5/4/1993 | NORTH CHINA PHARMACEUTICAL CORP | PENICILLIN G POTASSIUM CRUDE |
11041 | I | II | 6/24/1994 | SMITHKLINE BEECHAM PHARMACEUTICALS CO | PENICILLIN G POTASSIUM, NON-STERILE, TECHNICAL GRADE |
11516 | I | II | 5/19/1995 | CONSOLIDATED PHARMACEUTICAL GROUP INC | PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP |
11517 | I | II | 5/19/1995 | CONSOLIDATED PHARMACEUTICAL GROUP INC | PENICILLIN V POTASSIUM TABLETS, USP |
12094 | A | II | 8/20/1996 | JIANGXI DONGFENG PHARMACEUTICAL LLC | PENICILLIN G POTASSIUM (INDUSTRY GRADE) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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