Drug Master Files for: CYCLOBENZAPRINE HYDROCHLORIDE
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CYCLOBENZAPRINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18317 | A | II | 4/27/2005 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | CYCLOBENZAPRINE HYDROCHLORIDE |
| 21392 | A | II | 3/5/2008 | HETERO DRUGS LTD | CYCLOBENZAPRINE HYDROCHLORIDE |
| 21779 | A | II | 7/8/2008 | VASUDHA PHARMA CHEM LTD | CYCLOBENZAPRINE HCL USP |
| 23063 | I | II | 8/19/2009 | FLEMING LABORATORIES LTD | CYCLOBENZAPRINE HYDROCHLORIDE USP BULK |
| 23521 | A | II | 2/5/2010 | DERIVADOS QUIMICOS SAU | CYCLOBENZAPRINE HYDROCHLORIDE |
| 24719 | A | II | 3/26/2011 | JUBILANT GENERICS LTD | CYCLOBENZAPRINE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
