Details for New Drug Application (NDA): 021008

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NDA 021008 describes SANDOSTATIN LAR, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the SANDOSTATIN LAR profile page.

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

Summary for 021008

Tradename:	SANDOSTATIN LAR
Applicant:	Novartis
Ingredient:	octreotide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 021008

Antineoplastic Agents, Hormonal
Gastrointestinal Agents

Suppliers and Packaging for NDA: 021008

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008	NDA	Novartis Pharmaceuticals Corporation	0078-0811	0078-0811-81	1 KIT in 1 KIT (0078-0811-81) * 6 mL in 1 VIAL (0078-0790-61) * 2 mL in 1 SYRINGE
SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008	NDA	Novartis Pharmaceuticals Corporation	0078-0818	0078-0818-81	1 KIT in 1 KIT (0078-0818-81) * 6 mL in 1 VIAL (0078-0797-61) * 2 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/VIAL
Approval Date:	Nov 25, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 20MG BASE/VIAL
Approval Date:	Nov 25, 1998	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 30MG BASE/VIAL
Approval Date:	Nov 25, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021008

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	5,538,739*PED	⤷ Subscribe
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	Nov 25, 1998	5,538,739*PED	⤷ Subscribe
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	Nov 25, 1998	5,922,682*PED	⤷ Subscribe
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	5,922,338*PED	⤷ Subscribe
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998	5,753,618	⤷ Subscribe
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	4,395,403	⤷ Subscribe
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