Drug Master Files for: naratriptan hydrochloride
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naratriptan hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17648 | A | II | 8/30/2004 | DR REDDYS LABORATORIES LTD | NARATRIPTAN HYDROCHLORIDE |
22131 | A | II | 12/12/2008 | ORCHID PHARMA LTD | NARATRIPTAN HYDROCHLORIDE (NON-STERILE BULK API) |
22422 | I | II | 12/26/2008 | IND SWIFT LABORATORIES LTD | NARATRIPTAN HYDROCHLORIDE USP |
22621 | I | II | 3/13/2009 | APOTEX PHARMACHEM INDIA PVT LTD | NARATRIPTAN HYDROCHLORIDE USP |
22729 | A | II | 5/25/2009 | SUN PHARMACEUTICAL INDUSTRIES LTD | NARATRIPTAN HYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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