Drug Master Files for: benztropine mesylate
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benztropine mesylate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23719 | A | II | 6/4/2010 | ARCH PHARMALABS LTD | BENZTROPINE MESYLATE USP |
| 28840 | A | II | 12/3/2015 | CEDARBURG PHARMACEUTICALS INC | BENZTROPINE MESYLATE |
| 32136 | A | II | 2/9/2018 | NAVINTA LLC | BENZTROPINE MESYLATE USP |
| 33126 | A | II | 9/30/2018 | HARMAN FINOCHEM LTD | BENZTROPINE MESYLATE USP |
| 6189 | I | II | 1/30/1986 | ORION CORP LTD | BENZTROPINE MESYLATE |
| 6914 | A | II | 4/9/1987 | FINE CHEMICALS CORP PTY LTD | BENZTROPINE MESYLATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
