Ferring Pharmaceuticals |
55566100001 |
ganirelix |
2019-02-14 |
184.0200 |
None |
1 |
None |
1 |
None |
2018-12-14 |
None |
1 |
None |
1) report previously submitted so we do not agree we are delinquent 2)number of patients is non public |
None |
Fresenius Kabi USA LLC |
63323082320 |
Ertapenem for Injection, 1g Vial. (10 vials per pack) |
2019-12-09 |
1286.6000 |
None |
1 |
None |
None |
None |
2019-09-16 |
None |
1 |
The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed. |
The information contained in this report is subject to the following limitations and assumptions. (1) |
Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) |
Fresenius Kabi USA LLC |
65219016010 |
Busulfan Injection 60mg 10mL Vial (8 vials per pack) |
2019-12-04 |
2500.0000 |
None |
1 |
None |
None |
None |
2019-05-21 |
None |
1 |
The applicable dates were when Fresenius Kabi was granted a license to distribute the product in the United States. Fresenius Kabi does not own the regulatory approvals for the drug. The terms of the applicable deal are confidential, and therefore, will not be disclosed. |
The information contained in this report is subject to the following limitations and assumptions. (1) |
Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Fresenius Kabi USA believes is otherwise in the public domain or publicly available, as of the date of this submission. (2) |