Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018470
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.

03/06/1989 SUPPL-4 Labeling

Label is not available on this site.

06/29/1987 SUPPL-1 Labeling

Label is not available on this site.

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