Drug Master Files for: CELECOXIB
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CELECOXIB Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14929 | I | II | 6/20/2000 | NANO SYSTEMS | CELECOXIB 200 MG FILM COATED TABLETS |
16671 | A | II | 6/30/2003 | CIPLA LTD | CELECOXIB USP |
17697 | A | II | 9/22/2004 | MYLAN LABORATORIES LTD | CELECOXIB USP |
19155 | A | II | 1/19/2006 | CADILA PHARMACEUTICALS LTD | CELECOXIB USP |
19652 | A | II | 8/3/2006 | ERREGIERRE SPA | CELECOXIB USP-EP |
21921 | A | II | 9/2/2008 | DR REDDYS LABORATORIES LTD | CELECOXIB 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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