Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019667
Company: NOVARTIS

Products on NDA 19667

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SANDOSTATIN	OCTREOTIDE ACETATE	EQ 0.05MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
SANDOSTATIN	OCTREOTIDE ACETATE	EQ 0.1MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
SANDOSTATIN	OCTREOTIDE ACETATE	EQ 0.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
SANDOSTATIN	OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
SANDOSTATIN	OCTREOTIDE ACETATE	EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Labels for NDA 019667

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2023	SUPPL-76	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019667s076lbl.pdf
11/03/2023	SUPPL-76	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019667s076lbl.pdf
10/04/2022	SUPPL-73	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019667s073lbl.pdf
10/20/2021	SUPPL-71	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667Orig1s071lbl.pdf
05/25/2021	SUPPL-70	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019667s070lbl.pdf
04/11/2019	SUPPL-67	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019667s067lbl.pdf
02/21/2015	SUPPL-62	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019667Orig1s062lbl.pdf
03/23/2012	SUPPL-61	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019667s061lbl.pdf
01/25/2010	SUPPL-58	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019667s058,021008s023lbl.pdf
08/26/2008	SUPPL-54	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019667s054lbl.pdf
09/02/2005	SUPPL-50	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019667s050lbl.pdf
01/17/2003	SUPPL-44	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19667scm044_Sandostatin_lbl.pdf