Application 204928
- Type
- ANDA
- Sponsor
- RISING PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZAFIRLUKAST | ZAFIRLUKAST | TABLET;ORAL | 10MG | No | No |
| 002 | ZAFIRLUKAST | ZAFIRLUKAST | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-654 | Zafirlukast | Zafirlukast | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 16571-654 | Zafirlukast | Zafirlukast | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 16571-655 | Zafirlukast | Zafirlukast Tablets | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 16571-655 | Zafirlukast | Zafirlukast Tablets | Rising Pharmaceuticals, Inc. | ANDA | Current |