Drug Master Files for: erythromycin stearate
✉ Email this page to a colleague
erythromycin stearate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10087 | I | II | 4/11/1991 | PHARMACIA AND UPJOHN | ERYTHROMYCIN ENTERIC-COATED TABLETS |
12182 | I | II | 10/23/1996 | METABOLIC SOLUTIONS INC | ERYTHROMYCIN BREATH TEST DOSE |
13197 | A | II | 4/30/1998 | ABBVIE INC | ERYTHROMYCIN BASE |
13204 | I | II | 4/30/1998 | LILLY RESEARCH LABORATORIES | ERYTHROMYCIN ESTOLATE |
13293 | I | II | 9/1/1998 | ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV | ERYTHROMYCIN ETHYLSUCCINATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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