Drug Master Files for: citalopram hydrobromide
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citalopram hydrobromide Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12384 | A | II | 2/24/1997 | H LUNDBECK AS | CITALOPRAM HYDROBROMIDE |
14103 | A | II | 4/29/1999 | H LUNDBECK AS | ESCITALOPRAM OXALATE |
15587 | A | II | 8/21/2001 | JUBILANT GENERICS LTD | CITALOPRAM HYDROBROMIDE USP |
15813 | I | II | 1/17/2002 | CIPLA LTD | CITALOPRAM HYDROBROMIDE |
15836 | I | II | 1/31/2002 | SUMITOMO CHEMICAL CO LTD | CITALOPRAM HYDROBROMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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