Drug Master Files for: PEMETREXED DITROMETHAMINE
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PEMETREXED DITROMETHAMINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21180 | A | II | 1/3/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PEMETREXED DIACID |
| 22141 | A | II | 11/3/2008 | CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTD | PEMETREXED DISODIUM, (NON-STERILE BULK DRUG SUBSTANCE) |
| 23341 | A | II | 11/28/2009 | QILU PHARMACEUTICAL CO LTD | PEMETREXED DISODIUM |
| 23417 | A | II | 12/28/2009 | CHEMWERTH INC | PEMETREXED DISODIUM NON-STERILE BULK DRUG SUBSTANCE |
| 24327 | A | II | 11/1/2010 | SCINOPHARM TAIWAN LTD | PEMETREXED DISODIUM HEMIPENTAHYDRATE |
| 24388 | A | II | 11/23/2010 | DR REDDYS LABORATORIES LTD | PEMETREXED DISODIUM (AMORPHOUS) |
| 25102 | A | II | 9/21/2011 | SHILPA MEDICARE LTD | PEMETREXED DISODIUM (HEMIPENTA HYDRATE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
