Drug Master Files for: cromolyn
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cromolyn Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10006 | A | II | 12/15/1992 | FERMION OY | CROMOLYN SODIUM |
| 10736 | I | II | 2/18/1994 | SOCIETA ITALIANA MEDICINALI SCANDICCI | CROMOLYN SODIUM |
| 11050 | I | II | 8/26/1994 | FARMHISPANIA SA | CROMOLYN SODIUM |
| 11724 | I | II | 10/26/1995 | LIPHA SAS | CROMOLYN SODIUM |
| 1581 | I | II | 9/21/1970 | AVENTIS PHARMA SA | CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND |
| 1837 | I | 12/22/1971 | FISONS CORP | CROMOLYN SODIUM/LACTOSE BLEND | |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
