Drug Master Files for: Hec Pharm Co Ltd
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Hec Pharm Co Ltd Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
19443 | A | II | 3/20/2006 | HEC PHARM CO LTD | ERYTHROMYCIN THIOCYANATE, PHARMACEUTICAL INTERMEDIATE BULK FORM |
19444 | A | II | 3/20/2006 | HEC PHARM CO LTD | ERYTHROMYCIN USP, NON-STERILE BULK FORM |
20852 | I | II | 9/10/2007 | HEC PHARM CO LTD | AZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE |
23762 | A | II | 4/20/2010 | HEC PHARM CO LTD | ZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM |
24709 | A | II | 2/20/2011 | HEC PHARM CO LTD | CLARITHROMYCIN, NON-STERILE DRUG SUBSTANCE, BULK FORM |
26295 | A | II | 8/9/2012 | HEC PHARM CO LTD | LEVOFLOXACIN NON-STERILE BULK DRUG SUBSTANCE |
26763 | A | II | 12/28/2012 | HEC PHARM CO LTD | OLANZAPINE NON-STERILE BULK DRUG SUBSTANCE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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