Drug Master Files for: IPRATROPIUM BROMIDE
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IPRATROPIUM BROMIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14259 | A | II | 6/25/1999 | BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | IPRATROPIUM BROMIDE MONOHYDRATE |
| 15130 | A | II | 11/6/2000 | NEULAND LABORATORIES LTD | IPRATROPIUM BROMIDE |
| 21179 | A | II | 12/15/2007 | AARTI INDUSTRIES LTD | IPRATROPIUM BROMIDE |
| 23135 | I | II | 9/28/2009 | DERIVADOS QUIMICOS SA FINE CHEMICALS | IPRATROPIUM BROMIDE |
| 29843 | A | II | 10/1/2015 | CIPLA LTD | IPRATROPIUM BROMIDE USP |
| 31036 | A | II | 11/28/2017 | AMPHASTAR NANJING PHARMACEUTICALS INC | IPRATROPIUM BROMIDE USP |
| 8973 | A | II | 2/18/1991 | OLON SPA | IPRATROPIUM BROMIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
