Drug Master Files for: METHADONE HYDROCHLORIDE
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METHADONE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13942 | I | II | 1/18/1999 | BOEHRINGER INGELHEIM CHEMICALS INC | METHADONE HYDROCHLORIDE USP |
| 1508 | I | II | 3/25/1970 | LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO | 1-METHADONE HYDROCHLORIDE |
| 1515 | I | II | 4/23/1970 | MALLINCKRODT INC | METHADONE HYDROCHLORIDE |
| 1526 | I | II | 5/27/1970 | ELI LILLY AND CO | MANUF AND CONTROL INFOR. FOR METHADONE HYDROCHLORIDE DISPERSIBLE TBLS |
| 1607 | I | II | 11/28/1970 | VITARINE CO INC SUB WEST CHEMICAL PRODUCTS INC | METHADONE HCL EFFERVESCENT TABLETS, 40MG |
| 1802 | I | II | 9/21/1971 | MALLINCKRODT INC | METHADONE HCL FLAVORED CONCENTRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
