Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017684
Company: PHARMALUCENCE

Products on NDA 017684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYROLITE	TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT	N/A	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/1976	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/02/2000	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
02/07/2000	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/17/1998	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
03/23/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/13/1997	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/1989	SUPPL-14	Labeling		Label is not available on this site.
05/02/1989	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/10/1986	SUPPL-9	Efficacy-New Indication		Label is not available on this site.
11/17/1983	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/31/1983	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/04/1982	SUPPL-6	Labeling		Label is not available on this site.
08/11/1980	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/02/1983	SUPPL-1	Efficacy		Label is not available on this site.