Drug Master Files for: Novitium Pharma
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Novitium Pharma Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
27678 | A | II | 12/13/2013 | NOVITIUM PHARMA LLC | DAPSONE USP |
31249 | A | II | 1/27/2017 | NOVITIUM PHARMA LLC | DIAZOXIDE USP |
31250 | A | II | 1/2/2017 | NOVITIUM PHARMA LLC | NITISINONE |
31628 | A | II | 6/16/2017 | NOVITIUM PHARMA LLC | PRAZOSIN HYDROCHLORIDE USP |
31839 | A | II | 7/21/2017 | NOVITIUM PHARMA LLC | THIOTHIXENE USP |
31920 | A | II | 10/28/2017 | NOVITIUM PHARMA LLC | OXANDROLONE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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