Drug Master Files for: BENZYL ALCOHOL
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BENZYL ALCOHOL Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10253 | A | II | 5/12/1993 | NEULAND LABORATORIES LTD | BENZYL ALBUTEROL, INTERMEDIATE |
10268 | I | II | 6/3/1993 | WELLSPRING PHARMACEUTICAL CORP | DIBENZYLINE (SK&F 688-A) SOLUTION FOR INJECTION |
10602 | I | II | 11/23/1993 | BIOCHIMICA OPOS SPA | 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID, 4-NITROBENZYL ESTER HC1 |
11746 | I | II | 11/14/1995 | PHARM ECO LABORATORIES INC | (S)-N-BENZYL-N-[1,5,-BIS(4-PYRIDYL)-3-PENTYL]-3-(4CHLOROPHENYL)-2-{METHYL-[2-OXO-2-(3,4,5 TRIMETHOXYPHENYL) |
11898 | I | II | 3/11/1996 | CIS US INC | META-IODOBENZYLGUANIDINE SULFATE (MIBG-S) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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