Application 210048
- Type
- ANDA
- Sponsor
- MAIA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 0.5MG/ML | No | No |
| 002 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 2MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-678 | Baclofen | Baclofen | Sagent Pharmaceuticals | ANDA | Current |
| 25021-679 | Baclofen | Baclofen | Sagent Pharmaceuticals | ANDA | Current |
| 70511-122 | Baclofen (Intrathecal) | baclofen | MAlA Pharmaceuticals, Inc. | ANDA | Current |
| 70511-124 | Baclofen (Intrathecal) | baclofen | MAlA Pharmaceuticals, Inc. | ANDA | Current |