Drug Master Files for: AMPHETAMINE SULFATE
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AMPHETAMINE SULFATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10334 | A | II | 7/6/1993 | CHATTEM CHEMICALS INC | HYDROXYAMPHETAMINE HYDROBROMIDE USP |
1079 | I | 9/6/1967 | NYSCO LABS INC | DEXTRO-AMPHETAMINE SULFATE | |
11412 | I | V | 3/28/1995 | PHARMACO LIFE SCIENCE RESEARCH | METHOD GC32,GC ANALYSIS OF SELEGILINE IN HUMAN PLASMA AND METHOD GC33 REVISION 1, GC ANALYSIS OF AMPHETAMINE METHAPHETAMINE AND DESMETHYSELEGILINE IN HUMAN PLAS |
14783 | A | II | 3/17/2000 | JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS GROUP | DEXTROAMPHETAMINE SULFATE |
15088 | A | II | 10/13/2000 | JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS | AMPHETAMINE ASPARTATE |
15089 | A | II | 10/13/2000 | JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS | AMPHETAMINE SULFATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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