Drug Master Files for: AMINOLEVULINIC ACID HYDROCHLORIDE
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AMINOLEVULINIC ACID HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23711 | A | II | 4/6/2010 | NIPPON RIKA CO LTD | 5-AMINOLEVULINIC ACID HYDROCHLORIDE DRUG SUBSTANCE |
| 24359 | A | II | 11/12/2010 | HERAEUS DEUTSCHLAND GMBH AND CO KG | 5-AMINOLEVULINIC ACID HYDROCHLORIDE |
| 24562 | A | II | 12/27/2010 | MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH | 5-AMINOLEVULINIC ACID HYDROCHLORIDE 30 MG/ML POWDER FOR ORAL SOLUTION |
| 29376 | A | II | 5/27/2015 | MIDAS PHARMA GMBH | 5-AMINOLEVULINIC ACID HYDROCHLORIDE |
| 6194 | I | II | 1/30/1986 | SIGMA F AND D DIV LTD | DELTA-AMINOLEVULINIC ACID HCL |
| 9972 | A | II | 11/25/1992 | BACHEM SA | 5-AMINOLEVULINIC ACID HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
