Application 211397
- Type
- ANDA
- Sponsor
- VIRTUS PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALBUTEROL SULFATE | ALBUTEROL SULFATE | TABLET;ORAL | EQ 2MG BASE | No | No |
| 002 | ALBUTEROL SULFATE | ALBUTEROL SULFATE | TABLET;ORAL | EQ 4MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69543-290 | Albuterol | Albuterol | Virtus Pharmaceuticals LLC | ANDA | Current |
| 69543-290 | Albuterol | Albuterol | Virtus Pharmaceuticals LLC | ANDA | Current |
| 69543-291 | Albuterol | Albuterol | Virtus Pharmaceuticals LLC | ANDA | Current |
| 69543-291 | Albuterol | Albuterol | Virtus Pharmaceuticals LLC | ANDA | Current |
| 70954-078 | Albuterol | Albuterol | Novitium Pharma LLC | ANDA | Current |
| 70954-079 | Albuterol | Albuterol | Novitium Pharma LLC | ANDA | Current |