Drug Master Files for: citric
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citric Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
23078 | A | II | 8/28/2009 | JUNGBUNZLAUER LADENBURG GMBH | ANHYDROUS CITRIC ACID |
28708 | A | IV | 10/3/2014 | SD FINE CHEM LTD | CITRIC ACID ANHYDROUS USP |
28709 | A | IV | 10/3/2014 | SD FINE CHEM LTD | CITRIC ACID MONOHYDRATE BP |
31768 | A | IV | 9/6/2017 | INDIA PHOSPHATE | ANHYDROUS CITRIC ACID 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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