Application 210118
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ICATIBANT ACETATE | ICATIBANT ACETATE | INJECTABLE;SUBCUTANEOUS | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-3066 | Icatibant | Icatibant | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3066 | Icatibant | Icatibant | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3066 | Icatibant | Icatibant | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3066 | Icatibant | Icatibant | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3066 | Icatibant | Icatibant | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59595 | ORIG | 2019-08-06 |