Drug Master Files for: BIPERIDEN HYDROCHLORIDE
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BIPERIDEN HYDROCHLORIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15279 | I | III | 10/4/2000 | PLASDENE GLASS PAK | EFFECTS OF BIPERIDEN ON THE PHARMACOKINETICS OF HALOPERIDOL |
1540 | I | 6/25/1970 | KNOLL AG CHEMISCHE FABRIKEN | BIPERIDEN AND BIPERIDEN HYDROCHLORIDE (AKINETON) | |
2136 | I | III | 7/30/1973 | ARMSTRONG PRODUCTS CO | EFFECTS OF BIPERIDEN ON THE PHARMOKINETICS OF HALOPERIDOL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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