Drug Master Files for: ranitidine
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ranitidine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10273 | A | II | 5/27/1993 | UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) | RANITIDINE HYDROCHLORIDE (CRYSTALLINE FORM 1) |
| 10516 | I | II | 10/5/1993 | RANBAXY LABORATORIES LTD | RANITIDINE HYDROCHLORIDE |
| 10682 | I | II | 12/15/1993 | CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD | RANITIDINE HYDROCHLORIDE |
| 10885 | I | II | 4/25/1994 | NOVOPHARM LTD | RANITIDINE HYDROCHLORIDE USP |
| 10989 | I | II | 7/15/1994 | HEUMANN PHARMA GMBH AND CO | RANITIDINE HYDROCHLORIDE-FORM 1 |
| 10998 | I | II | 8/25/1994 | SIGNA SA DE CV | RANITIDINE HCL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
