Drug Master Files for: PROPANTHELINE BROMIDE
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PROPANTHELINE BROMIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17140 | A | II | 2/6/2004 | TOKUYAMA CORP | PROPANTHELINE BROMIDE |
1950 | I | 6/14/1972 | ACETO CHEMICAL CO INC | PROPANTHELINE BROMIDE BULK | |
2321 | I | II | 8/26/1974 | GANES CHEMICALS INC PENNSVILLE DIV | PROPANTHELINE BROMIDE |
3603 | I | II | 9/11/1979 | ERCOPHARM | PROPANTHELINE BROMIDE |
6469 | I | II | 6/15/1986 | HEXAGON LABORATORIES INC | PROPANTHELINE BROMIDE |
6633 | I | II | 10/14/1986 | TOKUYAMA CORP | FACILITIES PRODUCING PROPANTHELINE BROMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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