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Last Updated: December 1, 2023

Details for New Drug Application (NDA): 019667

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NDA 019667 describes SANDOSTATIN, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the SANDOSTATIN profile page.

The generic ingredient in SANDOSTATIN is octreotide acetate. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

Summary for 019667

Tradename:	SANDOSTATIN
Applicant:	Novartis
Ingredient:	octreotide acetate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019667

Mechanism of Action	Somatostatin Receptor Agonists

Medical Subject Heading (MeSH) Categories for 019667

Antineoplastic Agents, Hormonal
Gastrointestinal Agents

Suppliers and Packaging for NDA: 019667

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667	NDA	Novartis Pharmaceuticals Corporation	0078-0180	0078-0180-01	10 AMPULE in 1 PACKAGE (0078-0180-01) / 1 mL in 1 AMPULE (0078-0180-61)
SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667	NDA	Novartis Pharmaceuticals Corporation	0078-0181	0078-0181-01	10 AMPULE in 1 PACKAGE (0078-0181-01) / 1 mL in 1 AMPULE (0078-0181-61)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.05MG BASE/ML
Approval Date:	Oct 21, 1988	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.1MG BASE/ML
Approval Date:	Oct 21, 1988	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.5MG BASE/ML
Approval Date:	Oct 21, 1988	TE:	AP	RLD:	Yes

Expired US Patents for NDA 019667

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-005	Jun 12, 1991	⤷ Try a Trial	⤷ Try a Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-004	Jun 12, 1991	⤷ Try a Trial	⤷ Try a Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-003	Oct 21, 1988	⤷ Try a Trial	⤷ Try a Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-001	Oct 21, 1988	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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