Drug Master Files for: NATEGLINIDE
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NATEGLINIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17847 | A | II | 11/22/2004 | DR REDDYS LABORATORIES LTD | NATEGLINIDE (PREMIX) |
17906 | A | II | 12/13/2004 | CIPLA LTD | NATEGLINIDE USP |
17910 | A | II | 12/16/2004 | TEVA PHARMACEUTICAL INDUSTRIES LTD | NATEGLINIDE |
20231 | A | II | 1/27/2007 | IND SWIFT LABORATORIES LTD | NATEGLINIDE USP |
21484 | A | II | 3/25/2008 | UNICHEM LABORATORIES LTD | NATEGLINIDE |
21962 | I | II | 9/9/2008 | CADILA PHARMACEUTICALS LTD | NATEGLINIDE FORM B |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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