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Last Updated: December 6, 2019

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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. Eight 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021008
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:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/VIAL
Approval Date:Nov 25, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/VIAL
Approval Date:Nov 25, 1998TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 30MG BASE/VIAL
Approval Date:Nov 25, 1998TE:RLD:Yes

Expired US Patents for NDA 021008

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-003 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-003 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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