Drug Master Files for: Sterling
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Sterling Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1121 | I | I | 1/5/1968 | GLENBROOK LABORATORIES DIV STERLING DRUG INC | GENERAL DESCRIPTION OF FACILITIES, MANUFACTURING AND CONTROLS |
| 145 | I | 7/14/1954 | CENTAUR CALDWELL DIV STERLING DRUG INC | FACILITIES $ CONTROL | |
| 1497 | I | II | 3/19/1970 | WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC | FACILITIES, METHODS AND CONTROLS |
| 1498 | I | I | 3/9/1970 | WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC | MANUFACTURING DETAILS FOR SPECIFIC CHEMICALS |
| 1517 | I | II | 4/23/1970 | STERLING-WINTHROP RES INST DIV STERLING DRUG INC | AMINACRINE HYDROCHLORIDE |
| 15223 | I | II | 1/4/2001 | STERLING SRL | MEDROXYPROGESTERONE ACETATE |
| 1564 | I | II | 9/16/1970 | WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC | GR, CONTROL PROCEDURES & FACILITIES-MYERSTOWN, PA., PLANT |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
