Drug Master Files for: GLYCINE
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GLYCINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10656 | I | II | 1/7/1994 | SIGMA ALDRICH MANUFACTURING LLC | GLYCYLGLYCINE (PRODUCT NO. W 5310-8) |
| 11020 | I | II | 7/31/1994 | DERETIL SA | D(-) ALPHA PHENYLGLYCINE DANE SALT ETHYL NPOTASSIUM |
| 11021 | I | II | 7/31/1994 | DERETIL SA | D(-) ALPHA PARAHYDROXY PHENYLGLYCINE DANE SALT METHYL POTASSIUM |
| 11022 | I | II | 7/31/1994 | DERETIL SA | D(-) ALPHA DIHYDRO PHENYLGLYCINE DANE SALT METHYL SODIUM |
| 11122 | I | II | 9/30/1994 | DSM ANDENO GMBH | R(-)-2-PHENYLGLYCINE DANE SALT (POTASSIUM, ETHYL) (KE) |
| 11123 | I | II | 9/30/1994 | DSM ANDENO GMBH | R (-)-2-4-HYDROXY-PHENYLGLYCINE DANE SALT (POTASSIUM , METHYL) (DP) |
| 11256 | I | II | 12/21/1994 | DERETIL SA | D (-) ALPHA PHENYLGLYCINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
