Drug Master Files for: SERTRALINE HYDROCHLORIDE
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SERTRALINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14437 | A | II | 10/5/1999 | CIPLA LTD | SERTRALINE HYDROCHLORIDE USP (FORM-V) |
| 15731 | A | II | 11/14/2001 | HETERO DRUGS LTD | SERTRALINE HCL USP (FORM II PROCESS I) |
| 16009 | A | II | 6/11/2002 | DR REDDYS LABORATORIES LTD | SERTRALINE HYDROCHLORIDE (FORM II) |
| 16125 | I | II | 9/6/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | SERTRALINE HYDROCHLORIDE |
| 16752 | I | II | 8/8/2003 | PHF SA | SERTRALINE HYDROCHLORIDE |
| 16848 | I | II | 9/17/2003 | RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA | SERTRALINE HYDROCHLORIDE FORM II |
| 17317 | A | II | 4/15/2004 | CIPLA LTD | SERTRALINE HYDROCHLORIDE (FORM II) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
