Drug Master Files for: allopurinol
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allopurinol Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15841 | A | II | 2/4/2002 | SIGNA SA DE CV | ALLOPURINOL USP |
| 15945 | I | II | 4/18/2002 | LABORATORIO CHIMICO INTERNAZIONALE SPA | ALLOPURINOL |
| 16409 | A | II | 4/23/2003 | MYLAN LABORATORIES LTD | ALLOPURINOL USP |
| 16472 | A | II | 3/19/2003 | UNION QUIMICO FARMACEUTICA SA | ALLOPURINOL |
| 17128 | A | II | 1/28/2004 | HARMAN FINOCHEM LTD | ALLOPURINOL |
| 17855 | I | II | 10/28/2004 | AXITEC CO LTD | ALLOPURINOL USP |
| 21239 | A | II | 1/15/2008 | INDOCO REMEDIES LTD | ALLOPURINOL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
