Application 040905
- Type
- ANDA
- Sponsor
- KVK TECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KALEXATE | SODIUM POLYSTYRENE SULFONATE | POWDER;ORAL, RECTAL | 454GM/BOT | No | Yes |
| 002 | KALEXATE | SODIUM POLYSTYRENE SULFONATE | POWDER;ORAL, RECTAL | 15GM/BOT | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10702-036 | Sodium Polystyrene Sulfonate | Sodium Polystyrene Sulfonate | KVK-Tech, Inc. | ANDA | Current |
| 17856-0036 | Sodium Polystyrene Sulfonate | Sodium Polystyrene Sulfonate | Atlantic Biologicals Corps | ANDA | Current |
| 17856-1136 | Sodium Polystyrene Sulfonate | Sodium Polystyrene Sulfonate | ATLANTIC BIOLOGICALS CORP | ANDA | Current |
| 17856-1136 | Sodium Polystyrene Sulfonate | Sodium Polystyrene Sulfonate | ATLANTIC BIOLOGICALS CORP | ANDA | Current |