Generated: December 13, 2017
DrugPatentWatch Database Preview
Drug Master Files for: sertraline
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|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)|
|17325||A||II||4/20/2004||MYLAN LABORATORIES LTD||SERTRALINE HYDROCHLORIDE USP (FORM II) |
|17435||A||II||5/31/2004||AUROBINDO PHARMA LTD||SERTRALINE HYDROCHLORIDE USP (CRYSTALLINE POLYMORPH FORM II)|
|18049||I||II||2/3/2005||CADILA HEALTHCARE LTD||SERTRALINE HYDROCHLORIDE|
| This preview shows a limited data set|
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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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
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