Drug Master Files for: methenamine hippurate
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methenamine hippurate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16801 | A | II | 8/8/2003 | CYALUME SPECIALTY PRODUCTS INC | METHENAMINE HIPPURATE, USP |
| 27021 | A | II | 4/9/2013 | AUROBINDO PHARMA LTD | METHENAMINE HIPPURATE USP (NON-STERILE DRUG SUBSTANCE) |
| 28120 | A | II | 4/4/2014 | CHEMISCHE FABRIK BERG GMBH | METHENAMINE HIPPURATE |
| 29058 | A | II | 5/13/2015 | SAI LIFE SCIENCES LTD | METHENAMINE HIPPURATE USP |
| 31988 | A | II | 10/6/2017 | MICRO LABS LTD | METHENAMINE HIPPURATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
