Drug Master Files for: KETAMINE HYDROCHLORIDE
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KETAMINE HYDROCHLORIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
13141 | I | II | 8/18/1998 | DEGUSSA AG WERK RADEBEUL | KETAMINE HYDROCHLORIDE |
16737 | A | II | 7/31/2003 | CU CHEMIE UETIKON GMBH | S-KETAMINE HYDROCHLORIDE |
19082 | A | II | 12/16/2005 | FINE ORGANICS LTD | KETAMINE HYDROCHLORIDE |
22256 | I | II | 11/28/2008 | KAMUD DRUGS PVT LTD | KETAMINE HYDROCHLORIDE USP |
27921 | A | II | 1/15/2014 | SUPRIYA LIFESCIENCE LTD | KETAMINE HYDROCHLORIDE USP |
29094 | A | II | 4/14/2015 | AREVIPHARMA GMBH | KETAMINE HYDROCHLORIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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