| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 217630 | NDA | MAIA PHARMS INC | 001 | DAPTOMYCIN | POWDER;INTRAVENOUS | 350MG/VIAL | DAPTOMYCIN | 2024-11-21 | Discontinued | No | |
| 002 | DAPTOMYCIN | POWDER;INTRAVENOUS | 500MG/VIAL | DAPTOMYCIN | 2024-11-21 | Prescription | Yes | ||||
| 210850 | NDA | MAIA PHARMS INC | 001 | SINCALIDE | POWDER;INTRAVENOUS | 0.005MG/VIAL | SINCALIDE | 2022-11-22 | Prescription | Yes | |
| 215331 | NDA | MAIA PHARMS INC | 001 | BORTEZOMIB | SOLUTION;INTRAVENOUS | 3.5MG/3.5ML (1MG/ML) | BORTEZOMIB | 2022-07-27 | Discontinued | No | |
| 002 | BORTEZOMIB | SOLUTION;INTRAVENOUS | 3.5MG/1.4ML (2.5MG/ML) | BORTEZOMIB | 2022-07-27 | Discontinued | No | ||||
| 215025 | NDA | MAIA PHARMS INC | 001 | SODIUM PHENYLACETATE AND SODIUM BENZOATE | SOLUTION;INTRAVENOUS | 10%;10% (2GM/20ML;2GM/20ML) | SODIUM BENZOATE; SODIUM PHENYLACETATE | 2021-06-10 | Prescription | Yes | |
| 210777 | ANDA | MAIA PHARMS INC | 001 | BACLOFEN | INJECTABLE;INTRATHECAL | 0.05MG/ML | BACLOFEN | 2021-01-15 | Prescription | No | |
| 210048 | ANDA | MAIA PHARMS INC | 001 | BACLOFEN | INJECTABLE;INTRATHECAL | 0.5MG/ML | BACLOFEN | 2019-09-11 | Prescription | No | |
| 002 | BACLOFEN | INJECTABLE;INTRATHECAL | 2MG/ML | BACLOFEN | 2019-09-11 | Prescription | No | ||||
| 210315 | ANDA | MAIA PHARMS INC | 001 | BACLOFEN | INJECTABLE;INTRATHECAL | 1MG/ML | BACLOFEN | 2019-07-30 | Prescription | No | |
| 211215 | NDA | MAIA PHARMS INC | 001 | ANGIOMAX RTU | SOLUTION;INTRAVENOUS | 250MG/50ML (5MG/ML) | BIVALIRUDIN | 2019-07-25 | Prescription | Yes | |
| 208749 | ANDA | MAIA PHARMS INC | 001 | LEVOTHYROXINE SODIUM | POWDER;INTRAVENOUS | 100MCG/VIAL | LEVOTHYROXINE SODIUM | 2018-12-21 | Prescription | No | |
| 002 | LEVOTHYROXINE SODIUM | POWDER;INTRAVENOUS | 200MCG/VIAL | LEVOTHYROXINE SODIUM | 2018-12-21 | Prescription | No | ||||
| 003 | LEVOTHYROXINE SODIUM | POWDER;INTRAVENOUS | 500MCG/VIAL | LEVOTHYROXINE SODIUM | 2018-12-21 | Prescription | No | ||||
| 208521 | ANDA | MAIA PHARMS INC | 001 | SODIUM PHENYLACETATE AND SODIUM BENZOATE | SOLUTION;INTRAVENOUS | 10%;10% (5GM/50ML;5GM/50ML) | SODIUM BENZOATE; SODIUM PHENYLACETATE | 2017-05-08 | Prescription | No |