Application 008372
- Type
- NDA
- Sponsor
- MALLINCKRODT ARD
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | ACTHAR GEL (AUTOINJECTOR) | CORTICOTROPIN | INJECTABLE;INJECTION | 40 UNITS/0.5ML | Yes | Yes |
| 004 | ACTHAR GEL (AUTOINJECTOR) | CORTICOTROPIN | INJECTABLE;INJECTION | 80 UNITS/ML | Yes | Yes |
| 006 | H.P. ACTHAR GEL | CORTICOTROPIN | INJECTABLE;INJECTION | 40 UNITS/ML | No | No |
| 008 | H.P. ACTHAR GEL | CORTICOTROPIN | INJECTABLE;INJECTION | 80 UNITS/ML | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63004-8710 | Acthar | Repository Corticotropin | Mallinckrodt ARD LLC | NDA | Current |
| 63004-8710 | Acthar | Repository Corticotropin | Mallinckrodt ARD LLC | NDA | Current |
| 63004-8710 | Acthar | Repository Corticotropin | Mallinckrodt ARD LLC | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 77683 | SUPPL | 2024-03-01 |
| 77681 | SUPPL | 2024-03-01 |
| 77680 | SUPPL | 2024-03-01 |
| 73595 | SUPPL | 2023-02-23 |
| 69179 | SUPPL | 2021-11-01 |
| 69173 | SUPPL | 2021-10-29 |
| 69172 | SUPPL | 2021-10-29 |
| 66472 | SUPPL | 2021-03-03 |
| 66471 | SUPPL | 2021-03-03 |
| 66460 | SUPPL | 2021-03-03 |
| 58092 | SUPPL | 2019-03-27 |
| 58081 | SUPPL | 2019-03-27 |
| 53889 | SUPPL | 2018-05-01 |
| 53826 | SUPPL | 2018-04-27 |
| 32963 | SUPPL | 2015-05-08 |
| 150 | SUPPL | 2015-03-25 |
| 98 | SUPPL | 2012-07-09 |