Drug Master Files for: ritonavir
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ritonavir Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11666 | I | II | 9/11/1995 | FINORGA SAS | RITONAVIR |
| 11672 | A | II | 9/22/1995 | PRIME EUROPEAN THERAPEUTICALS SPA (EUTICALS SPA) | A-84538.0 (RITONAVIR) |
| 11677 | I | II | 9/25/1995 | AJINOMOTO CO INC | A-84538.0 (RITONAVIR) |
| 12747 | I | II | 11/17/1997 | CATALENT PHARMA SOLUTIONS LLC | RITONAVIR, 100MG AND 200MG SOFT-GELATIN CAPSULE |
| 14807 | I | II | 3/29/2000 | CATALENT PHARMA SOLUTIONS LLC | LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES |
| 19037 | A | II | 12/9/2005 | AUROBINDO PHARMA LTD | RITONAVIR USP |
| 19800 | A | II | 9/26/2006 | MYLAN LABORATORIES LTD | RITONAVIR USP (FORM-II) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
