Drug Master Files for: CAPTOPRIL
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CAPTOPRIL Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11228 | I | II | 12/16/1994 | BORYUNG PHARMACEUTICAL CO LTD | CAPTOPRIL |
11904 | I | II | 3/29/1996 | SHANDONG WEI FANG PHARMACEUTICAL FACTORY | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CAPTOPRIL USP IN SHANDONG, PEOPLES REPUBLIC OF CHINA. |
11905 | A | II | 3/29/1996 | ZHONGFU PHARMACEUTICAL CO LTD | CAPTOPRIL USP |
12672 | I | II | 9/23/1997 | SINOVA PHARMACEUTICALS CO PTE LTD | CAPTOPRIL |
14311 | A | II | 7/22/1999 | ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD | CAPTOPRIL USP |
32247 | A | II | 12/4/2017 | MEDICHEM SA | CAPTOPRIL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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