Drug Master Files for: MEPERIDINE HYDROCHLORIDE
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MEPERIDINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11345 | A | II | 2/10/1995 | SPECGX LLC | MEPERIDINE HYDROCHLORIDE, USP |
| 11636 | I | II | 8/30/1995 | MALLINCKRODT INC | MEPERIDINE HYDROCHLORIDE INJECTION USP 10MG/ML |
| 11749 | I | II | 11/17/1995 | HOECHST AG | BULK MEPERIDINE HYDROCHLORIDE USP (PETHIDINE HYDROCHLORIDE EP) DRUG SUBSTANCE |
| 12944 | I | II | 4/9/1998 | JOHNSON MATTHEY INC | MEPERIDINE HCI, USP |
| 4525 | A | II | 4/20/1982 | AMRI RENSSELAER INC | MEPERIDINE HCL USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
