Drug Master Files for: chlorpheniramine maleate
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chlorpheniramine maleate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17311 | A | II | 4/1/2004 | SPECGX LLC | CHLORPHENIRAMINE POLISTIREX |
21003 | I | II | 10/31/2007 | GRANULES INDIA LTD | Chlorpheniramine Maleate USP |
21355 | A | II | 2/5/2008 | KESHAVA ORGANICS PVT LTD | DEXCHLORPHENIRAMINE MALEATE |
21356 | A | II | 2/5/2008 | KESHAVA ORGANICS PVT LTD | CHLORPHENIRAMINE MALEATE |
21719 | I | II | 5/19/2008 | HARIKA DRUGS PRIVATE LTD | CHLORPHENIRAMINE TANNATE |
22210 | A | II | 11/13/2008 | SUPRIYA LIFESCIENCE LTD | CHLORPHENIRAMINE MALEATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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