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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. There are two patents protecting this drug. Additional details are available on the SANDOSTATIN LAR profile page.

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

Summary for NDA: 021008

Tradename:
SANDOSTATIN LAR
Applicant:
Novartis
Ingredient:
octreotide acetate
Patents:2
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

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 0078-0340 0078-0340-61 1 KIT in 1 KIT (0078-0340-61) * 2.5 mL in 1 SYRINGE * .75 mL in 1 PACKET * 5 mL in 1 VIAL, SINGLE-USE
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION 021008 NDA Novartis Pharmaceuticals Corporation 0078-0341 0078-0341-61 1 KIT in 1 KIT (0078-0341-61) * 5 mL in 1 VIAL, SINGLE-USE * 2.5 mL in 1 SYRINGE * .75 mL in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/VIAL
Approval Date:Nov 25, 1998TE:RLD:No
Patent:5,922,338*PEDPatent Expiration:Jan 13, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:5,922,682*PEDPatent Expiration:Jan 13, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 20MG BASE/VIAL
Approval Date:Nov 25, 1998TE:RLD:No
Patent:5,922,338*PEDPatent Expiration:Jan 13, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book 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;INJECTION021008-002Nov 25, 19985,639,480*PED► subscribe
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 19984,395,403► subscribe
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 19985,688,530*PED► subscribe
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