Drug Master Files for: IBUPROFEN
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IBUPROFEN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10165 | A | II | 3/26/1993 | ADARE PHARMACEUTICALS INC | IBUPROFEN GELATIN/CAP |
| 10499 | A | II | 9/29/1993 | CATALENT PHARMA SOLUTIONS LLC | IBUPROFEN SOFTGELS, 200 MG. |
| 11202 | I | II | 11/15/1994 | UNITED BREWERIES LTD | IBUPROFEN USP |
| 11243 | I | II | 11/29/1994 | SHANDONG XIN HUA PHARMACEUTICAL FACTORY | IBUPROFEN BP 88/USP XXII |
| 12036 | A | II | 7/3/1996 | SOLARA A PHARMA SCIENCES LTD | S-IBUPROFEN |
| 12669 | I | II | 9/22/1997 | WANBURY LTD | IBUPROFEN BULK DRUG |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
