Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209358
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/10/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CALCITONIN-SALMON
INJECTABLE;INJECTION; 200 IU/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213766 | CIPLA |
CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212416 | CUSTOPHARM INC |
CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215715 | DR REDDYS |
CALCITONIN-SALMON | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209358 | ENDO OPERATIONS |
MIACALCIN | CALCITONIN SALMON | 200 IU/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017808 | MYLAN IRELAND LTD |