Drug Master Files for: phenylbutazone
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phenylbutazone Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1548 | I | II | 7/23/1970 | AMSA ANONIMA MEDICINALI SINTETICI AND AFFINI SPA | PHENYLBUTAZONE |
1702 | I | II | 12/17/1970 | INQUIME INDS QUIMECA ESTENE SA | PHENYLBUTAZONE USP |
1769 | I | 7/26/1971 | AS SYNTHETICS | PHENYLBUTAZONE | |
1826 | I | 12/6/1971 | ALLIED CHEM CORP | PHENYLBUTAZONE | |
1925 | I | II | 5/1/1972 | RP SCHERER CORP | PHENYLBUTAZONE CAPSULES 100MG |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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