Drug Master Files for: Luitpold
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Luitpold Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15235 | I | II | 12/21/2000 | LUITPOLD PHARMACEUTICALS INC | STERILE WATER FOR INJECTION,USP |
15236 | I | II | 12/28/2000 | LUITPOLD PHARMACEUTICALS INC | NEUTRA-CAINE (SODIUM BICARBONATE INJECTION) USP 7.5% |
15237 | A | II | 12/28/2000 | LUITPOLD PHARMACEUTICALS INC | METHYLENE BLUE INJECTION, USP 1% |
15659 | I | II | 10/10/2001 | LUITPOLD PHARMACEUTICALS INC | SODIUM CHLORIDE INJECTION 0.9% 4ML FILL IN A 5ML VIAL |
20715 | A | II | 7/26/2007 | LUITPOLD PHARMACEUTICALS INC | SODIUM THIOSULFATE INJECTION, USP 25% ML VIAL |
21544 | I | II | 4/17/2008 | LUITPOLD PHARMACEUTICALS INC | SODIUM CHLORIDE INJECTION USP 0.9% |
22618 | I | V | 3/10/2009 | LUITPOLD PHARMACEUTICALS INC | SUPPORTING FACILITY, EQUIPMENT & VALIDATION INFORMATION MANUFACTURING FACILITY IN SHIRLEY, NY |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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