Drug Master Files for: LORATADINE
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LORATADINE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11803 | A | II | 12/19/1995 | QUIMICA SINTETICA SA | LORATADINE |
12650 | A | II | 9/11/1997 | MOREPEN LABORATORIES LTD | LORATADINE |
13032 | A | II | 6/18/1998 | MSD INTERNATIONAL GMBH | LORATADINE |
13811 | I | II | 10/20/1998 | INKE SA | LORATADINE |
13842 | I | II | 11/12/1998 | MEDICHEM SA | LORATADINE |
14155 | A | II | 5/26/1999 | ROLABO OUTSOURCING SL | LORATADINE USP |
15251 | A | II | 1/17/2001 | SUN PHARMACEUTICAL INDUSTRIES LTD | LORATADINE USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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