Drug Master Files for: clomipramine hydrochloride
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clomipramine hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10949 | A | II | 6/2/1994 | SIGMA ALDRICH IRELAND LTD | CLOMIPRAMINE HYDROCHLORIDE |
13021 | A | II | 6/15/1998 | TARO PHARMACEUTICAL INDUSTRIES LTD | CLOMIPRAMINE HYDROCHLORIDE USP |
13127 | I | II | 8/12/1998 | EVONIK TECHNOCHEMIE GMBH | CLOMIPRAMINE HYDROCHLORIDE |
15811 | I | II | 1/14/2002 | PCAS | CLOMIPRAMINE HCL |
30814 | A | II | 8/20/2016 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | CLOMIPRAMINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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