Drug Master Files for: BENZONATATE
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BENZONATATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12327 | A | II | 1/21/1997 | CATALENT PHARMA SOLUTIONS LLC | TESSALON 100 MG AND 200 MG SOFTGEL CAPSULES AND BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES |
12421 | I | II | 3/14/1997 | NOVARTIS PHARMACEUTICALS CORP | TESSALON DRUG SUBSTANCE, (BENZONATATE, USP) |
21703 | A | II | 6/16/2008 | FORMOSA LABORATORIES INC | BENZONATATE USP |
24194 | I | II | 9/20/2010 | KINGLAND CHEMICALS CO LTD | BENZONATATE |
5196 | A | II | 12/13/1983 | ALBEMARLE CORP | BENZONATATE USP XX |
7843 | A | II | 12/19/1988 | SIEGFRIED EVIONNAZ SA | BENZONATATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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