Drug Master Files for: levalbuterol hydrochloride
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levalbuterol hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18236 | A | II | 4/1/2005 | FINE CHEMICALS CORP PTY LTD | LEVALBUTEROL HYDROCHLORIDE |
| 18433 | A | II | 6/16/2005 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LEVALBUTEROL HYDROCHLORIDE |
| 19131 | A | II | 1/25/2006 | CIPLA LTD | LEVALBUTEROL HYDROCHLORIDE USP |
| 20142 | A | II | 1/10/2007 | JOHNSON MATTHEY PHARMA SERVICES | LEVALBUTEROL HCI |
| 20557 | A | II | 5/23/2007 | AARTI INDUSTRIES LTD | LEVALBUTEROL HCL |
| 21394 | I | II | 3/5/2008 | FDC LTD | LEVALBUTEROL HYDROCHLORIDE |
| 24548 | A | II | 1/4/2011 | ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTD | LEVALBUTEROL L-TARTRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
