Drug Master Files for: CYSTEINE HYDROCHLORIDE
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CYSTEINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10741 | I | II | 2/28/1994 | NIPPON RIKAGAKUYAKUHIN CO LTD | CYSTEINE HYDROCHLORIDE |
| 14304 | A | II | 7/21/1999 | MOEHS IBERICA SL | ACETYLCYSTEINE USP |
| 1930 | I | II | 5/9/1972 | TANABE SEIYAKU CO LTD | L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE |
| 21364 | A | II | 2/26/2008 | NIPPON PROTEIN CO LTD | L-CYSTEINE HYDROCHLORIDE MONOHYDRATE |
| 21789 | A | II | 7/10/2008 | NIPPON RIKA CO LTD | ACETYLCYSTEINE DRUG SUBSTANCE |
| 3478 | I | II | 2/9/1979 | WAITAKI INTERNATIONAL BIOSCIENCES SUB WAITAKI CANADA LTD | N-ACETYL-L-CYSTEINE |
| 5049 | I | II | 6/30/1983 | DIAMALT AG | S-CARBOXYMATHYL-L-CYSTEINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
