Application 211832
- Type
- ANDA
- Sponsor
- TWI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TERBUTALINE SULFATE | TERBUTALINE SULFATE | TABLET;ORAL | 2.5MG | No | No |
| 002 | TERBUTALINE SULFATE | TERBUTALINE SULFATE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24979-132 | Terbutaline Sulfate | Terbutaline Sulfate | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-133 | Terbutaline Sulfate | Terbutaline Sulfate | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 71205-938 | Terbutaline Sulfate | Terbutaline Sulfate | Proficient Rx LP | ANDA | Current |
| 71205-938 | Terbutaline Sulfate | Terbutaline Sulfate | Proficient Rx LP | ANDA | Current |
| 71205-939 | Terbutaline Sulfate | Terbutaline Sulfate | Proficient Rx LP | ANDA | Current |
| 71205-939 | Terbutaline Sulfate | Terbutaline Sulfate | Proficient Rx LP | ANDA | Current |