Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018467
Company: SUN PHARM INDS INC

Products on NDA 018467

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018467

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/1982	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
10/30/2015	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
04/25/2013	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
05/16/2002	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/15/2000	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/07/2000	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/05/1997	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/29/1993	SUPPL-14	Efficacy-New Indication	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018467-S13&S14_Hepatolite_toc.cfm
12/29/1993	SUPPL-13	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018467-S13&S14_Hepatolite_toc.cfm
05/02/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/19/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/19/1989	SUPPL-10	Labeling		Label is not available on this site.
05/19/1989	SUPPL-9	Efficacy-New Indication		Label is not available on this site.
05/19/1989	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/28/1986	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/21/1983	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/1983	SUPPL-2	Labeling		Label is not available on this site.
04/26/1983	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.