Drug Master Files for: carisoprodol
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carisoprodol Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17400 | I | II | 5/19/2004 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | CARISOPRODOL |
17444 | A | II | 6/3/2004 | UQUIFA ITALIA SPA | CARISOPRODOL USP |
19161 | I | II | 2/8/2006 | SUN PHARMACEUTICAL INDUSTRIES LTD | CARISOPRODOL USP (A SUBSTANCE) |
19388 | A | II | 4/18/2006 | AUROBINDO PHARMA LTD | CARISOPRODOL USP |
19408 | I | II | 5/5/2006 | ISOCHEM SAS | CARISOPRODOL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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