Drug Master Files for: ZOLEDRONIC ACID
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ZOLEDRONIC ACID Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18964 | I | II | 11/18/2005 | PISGAH LABS INC | ZOLEDRONIC ACID MONOHYDRATE (A PHARMACEUTICAL INGREDIENT) |
| 19523 | A | II | 6/15/2006 | NATCO PHARMA LTD | ZOLEDRONIC ACID |
| 19701 | A | II | 8/22/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ZOLEDRONIC ACID |
| 19749 | A | II | 8/24/2006 | CIPLA LTD | ZOLEDRONIC ACID |
| 20052 | A | II | 12/16/2006 | JUBILANT GENERICS LTD | ZOLEDRONIC ACID |
| 20574 | A | II | 5/31/2007 | SUN PHARMACEUTICAL INDUSTRIES LTD | ZOLEDRONIC ACID MONOHYDRATE |
| 21011 | A | II | 10/31/2007 | WOCKHARDT LTD | ZOLEDRONIC ACID MONOHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
