Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018470
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIBACALCIN | CALCITONIN HUMAN | 0.5MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/18/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/17/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/06/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 06/29/1987 | SUPPL-1 | Labeling |
Label is not available on this site. |