Drug Master Files for: lopinavir
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lopinavir Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14807 | I | II | 3/29/2000 | CATALENT PHARMA SOLUTIONS LLC | LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES |
19600 | I | II | 7/17/2006 | MYLAN LABORATORIES LTD | LOPINAVIR (LVR) |
19852 | A | II | 10/10/2006 | HETERO LABS LTD | LOPINAVIR USP |
19862 | A | II | 10/9/2006 | AUROBINDO PHARMA LTD | LOPINAVIR (NON STERILE DRUG SUBSTANCE) |
20363 | A | II | 5/30/2007 | MYLAN LABORATORIES LTD | LOPINAVIR USP (LOP) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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