Drug Master Files for: ACYCLOVIR SODIUM
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ACYCLOVIR SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10044 | A | II | 1/12/1993 | RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA | ACYCLOVIR |
| 10124 | I | II | 3/2/1993 | OMNICHEM SA | ACYCLOVIR |
| 10685 | A | II | 1/12/1994 | OLON SPA | ACYCLOVIR |
| 10710 | I | II | 2/7/1994 | CIPLA LTD | ACYCLOVIR |
| 10830 | A | II | 3/24/1994 | YUNG ZIP CHEMICAL IND CO LTD | ACYCLOVIR |
| 10945 | A | II | 6/9/1994 | EXCELLA GMBH AND CO KG | ACYCLOVIR SODIUM |
| 11352 | I | II | 2/20/1995 | LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL CO | ACYCLOVIR A SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
