Drug Master Files for: ESMOLOL HYDROCHLORIDE
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ESMOLOL HYDROCHLORIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15743 | I | II | 11/30/2001 | BOEHRINGER INGELHEIM LTD | ESMOLOL HCL |
16053 | A | II | 6/27/2002 | CHEMWERTH INC | ESMOLOL HCL |
16863 | A | II | 9/24/2003 | TARO PHARMACEUTICAL INDUSTRIES LTD | ESMOLOL HYDROCHLORIDE |
26024 | A | II | 5/3/2012 | MSN LABORATORIES PRIVATE LTD | ESMOLOL HYDROCHLORIDE USP [ROUTE CODE-EH] |
4475 | A | II | 3/12/1982 | DELMAR CHEMICALS INC | ESMOLOL HYDROCHLORIDE |
5126 | I | II | 11/3/1983 | GANES CHEMICALS INC PENNSVILLE DIV | ESMOLOL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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