Drug Master Files for: RITODRINE HYDROCHLORIDE
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RITODRINE HYDROCHLORIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10315 | I | II | 6/16/1993 | LUSOCHIMICA SPA | RITODRINE HYDROCHLORIDE |
3490 | I | II | 3/6/1979 | DUPHAR BV | RITODRINE HCL |
4527 | I | II | 4/26/1982 | DUPHAR BV | YUTOPAR (RITODRINE HCL) TABLETS & INJECTION FORMS,OLST,HOLLAND |
6173 | I | II | 1/3/1986 | ORION CORP LTD | RITODRINE HCL |
6264 | I | II | 4/14/1986 | OY STAR AB | RITODRINE HCL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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