Drug Master Files for: escitalopram oxalate
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escitalopram oxalate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14103 | A | II | 4/29/1999 | H LUNDBECK AS | ESCITALOPRAM OXALATE |
| 16636 | A | II | 6/12/2003 | CIPLA LTD | ESCITALOPRAM OXALATE |
| 17960 | A | II | 12/29/2004 | HETERO LABS LTD | ESCITALOPRAM OXALATE (PROCESS-I) |
| 18119 | A | II | 2/25/2005 | CADILA HEALTHCARE LTD | ESCITALOPRAM OXALATE USP |
| 18213 | A | II | 3/30/2005 | MYLAN LABORATORIES LTD | ESCITALOPRAM OXALATE USP |
| 18342 | I | II | 5/9/2005 | DR REDDYS LABORATORIES LTD | ESCITALOPRAM OXALATE |
| 19088 | A | II | 12/24/2005 | AUROBINDO PHARMA LTD | ESCITALOPRAM OXALATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
