Drug Master Files for: sorbitol
✉ Email this page to a colleague
sorbitol Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10879 | I | IV | 4/15/1994 | ROQUETTE AMERICA INC | NEOSORB 70/20 SORBITOL SOLUTION |
11651 | I | IV | 1/3/1996 | SPI PHARMA INC | SORBITOL SPECIAL (PLASTICIZER) |
1922 | I | 4/27/1972 | CUTTER LABORATORIES INC | CONCENTRATED PERITONEAL DIALYZING SOLUTIONS WITH SORBITOL | |
2055 | I | II | 1/30/1973 | MCGAW INC | SORBITOL IN PERITONEAL DIALYSIS SOL. |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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