Drug Master Files for: AMINOCAPROIC ACID
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AMINOCAPROIC ACID Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1039 | I | II | 3/9/1967 | NAFTONE INC | 6-AMINOCAPROIC ACID |
30439 | A | II | 3/24/2016 | SUNNY PHARMTECH INC | AMINOCAPROIC ACID, USP |
31132 | A | II | 12/14/2016 | DIPHARMA FRANCIS SRL | AMINOCAPROIC ACID |
31478 | A | II | 4/26/2017 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | AMINOCAPROIC ACID |
33134 | A | II | 9/29/2018 | MSN LIFE SCIENCES PRIVATE LTD | AMINOCAPROIC ACID USP |
33407 | A | II | 12/19/2018 | OPTIMUS DRUGS PRIVATE LTD | AMINOCAPROIC ACID |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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