Drug Master Files for: pentamidine isethionate
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pentamidine isethionate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10316 | I | II | 6/25/1993 | SIPSY CHIMIE FINE SCA | PENTAMIDINE ISETHIONATE |
31636 | A | II | 10/11/2017 | RELIABLE BIOPHARMACEUTICAL LLC | PENTAMIDINE ISETHIONATE USP |
5280 | I | II | 4/20/1984 | ALDRICH CHEMICAL CO INC | PENTAMIDINE ISETHIONATE (PRODUCT W149-5) |
6288 | I | II | 12/13/1985 | RHONE POULENC RORER INC | PENTAMIDINE ISETHIONATE |
6447 | I | II | 7/2/1986 | MACFARLAN SMITH JOHNSON MATTHEY PLC BUSINESS | PENTAMIDINE ISETHIONATE,(BULK) |
6492 | A | II | 7/23/1986 | DELMAR CHEMICALS INC | PENTAMIDINE ISETHIONATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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