Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017454
Company: MALLINCKRODT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSTEOSCAN TECHNETIUM TC-99M ETIDRONATE KIT N/A 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
09/28/1973 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/1980 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/25/1979 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1978 SUPPL-18 Efficacy

Label is not available on this site.

02/24/1978 SUPPL-17 Labeling

Label is not available on this site.

07/17/1979 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/17/1979 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1977 SUPPL-13 Labeling

Label is not available on this site.

02/11/1977 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1977 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1977 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/04/1976 SUPPL-9 Labeling

Label is not available on this site.

03/04/1976 SUPPL-8 Labeling

Label is not available on this site.

03/04/1976 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

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