Application 204734
- Type
- NDA
- Sponsor
- SHIRE DEV LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FOSRENOL | LANTHANUM CARBONATE | POWDER;ORAL | EQ 750MG BASE | Yes | No |
| 002 | FOSRENOL | LANTHANUM CARBONATE | POWDER;ORAL | EQ 1GM BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 54092-256 | Fosrenol | lanthanum carbonate | Shire US Manufacturing Inc. | NDA | Current |
| 54092-256 | Fosrenol | lanthanum carbonate | Shire US Manufacturing Inc. | NDA | Current |
| 54092-256 | Fosrenol | lanthanum carbonate | Shire US Manufacturing Inc. | NDA | Current |
| 54092-256 | Fosrenol | lanthanum carbonate | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-257 | Fosrenol | lanthanum carbonate | Shire US Manufacturing Inc. | NDA | Current |
| 54092-257 | Fosrenol | lanthanum carbonate | Shire US Manufacturing Inc. | NDA | Current |
| 54092-257 | Fosrenol | lanthanum carbonate | Shire US Manufacturing Inc. | NDA | Current |
| 54092-257 | Fosrenol | lanthanum carbonate | Takeda Pharmaceuticals America, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79527 | SUPPL | 2024-09-03 |
| 79515 | SUPPL | 2024-09-02 |
| 79514 | SUPPL | 2024-09-02 |
| 76789 | SUPPL | 2023-12-13 |
| 76782 | SUPPL | 2023-12-13 |
| 74225 | SUPPL | 2023-05-11 |
| 74222 | SUPPL | 2023-05-11 |
| 62915 | SUPPL | 2020-05-12 |
| 62914 | SUPPL | 2020-05-12 |
| 62911 | SUPPL | 2020-05-12 |
| 56676 | SUPPL | 2018-12-07 |
| 56414 | SUPPL | 2018-11-12 |
| 56413 | SUPPL | 2018-11-12 |
| 44982 | SUPPL | 2016-02-24 |
| 44981 | SUPPL | 2016-02-24 |
| 44985 | ORIG | 2014-09-24 |
| 44984 | ORIG | 2014-09-24 |
| 44980 | ORIG | 2014-09-24 |
| 44979 | ORIG | 2014-09-24 |