Application 216434
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUMETANIDE | BUMETANIDE | INJECTABLE;INJECTION | 0.25MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65219-570 | Bumetanide | Bumetanide | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-572 | Bumetanide | Bumetanide | Fresenius Kabi USA, LLC | ANDA | Current |
| 68083-496 | Bumetanide | Bumetanide | Gland Pharma Limited | ANDA | Current |
| 68083-497 | Bumetanide | Bumetanide | Gland Pharma Limited | ANDA | Current |
| 68462-469 | Bumetanide | Bumetanide | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-470 | Bumetanide | Bumetanide | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |