Drug Master Files for: ICATIBANT ACETATE
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ICATIBANT ACETATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20862 | A | II | 9/17/2007 | BACHEM AG | ICATIBANT ACETATE |
| 28496 | A | II | 3/9/2015 | CHENGDU SHENGNUO BIOPHARM CO LTD | ICATIBANT ACETATE |
| 29213 | A | II | 3/26/2015 | BCN PEPTIDES SA | ICATIBANT ACETATE |
| 29225 | A | II | 5/22/2015 | AMBIOPHARM INC | ICATIBANT ACETATE (NON-STERILE) |
| 30476 | A | II | 6/9/2016 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ICATIBANT ACETATE |
| 30526 | A | II | 9/27/2016 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | ICATIBANT ACETATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
