Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017454
Company: MALLINCKRODT

Products on NDA 017454

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017454

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.