Drug Master Files for: pancrelipase
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pancrelipase Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10883 | I | II | 4/19/1994 | EURAND SPA | PANCRELIPASE (ULTRASE) MINITABS |
12032 | I | II | 7/5/1996 | NORDMARK ARZNEIMITTEL GMBH | PANCRELIPASE ENTERIC COATED MICROTABLETS |
15447 | I | II | 5/15/2001 | YUNG SHIN PHARMACEUTICAL INDUSTRIES CO LTD | PANCRELIPASE CR PELLETS |
15681 | A | II | 10/15/2001 | ADARE PHARMACEUTICALS SRL | PANCRELIPASE PRODUCTS (EURAND MINITABS) (HP55) |
7090 | A | II | 7/28/1987 | NORDMARK ARZNEIMITTEL GMBH AND CO KG | PANCRELIPASE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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