Application 091141
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FORMOTEROL FUMARATE | FORMOTEROL FUMARATE | SOLUTION;INHALATION | 20MCG/2ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-4061 | Formoterol fumarate | Formoterol fumarate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4061 | Formoterol fumarate | Formoterol fumarate | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 63629-8813 | Formoterol fumarate | Formoterol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8813 | Formoterol fumarate | Formoterol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8814 | Formoterol fumarate | Formoterol fumarate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8814 | Formoterol fumarate | Formoterol fumarate | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63412 | ORIG | 2020-06-04 |