Drug Master Files for: guaifenesin
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guaifenesin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10413 | A | II | 8/13/1993 | SYNTHOKEM LABS PRIVATE LTD | GUAIFENESIN USP |
| 10988 | I | II | 7/19/1994 | SIANG TA PHARMACEUTICAL CO LTD | GUAIFENESIN |
| 14234 | A | II | 6/24/1999 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | GUAIFENESIN USP |
| 14372 | A | II | 8/30/1999 | GRANULES INDIA LTD | GUAIFENESIN USP |
| 15507 | I | II | 6/28/2001 | BOEHRINGER INGELHEIM CHEMICALS INC | GUAIFENESIN USP |
| 16122 | A | II | 9/4/2002 | SEVEN STAR PHARMACEUTICAL CO LTD | GUAIFENESIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
