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Generated: December 15, 2017

DrugPatentWatch Database Preview

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 eighteen 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 021008

Tradename:1
Applicant:1
Ingredient:1
Patents:2
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
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 0078-0646 0078-0646-81 1 VIAL, SINGLE-USE in 1 KIT (0078-0646-81) > 1 KIT in 1 VIAL, SINGLE-USE (0078-0646-61) * 6 mL in 1 VIAL, SINGLE-USE * 2 mL in 1 SYRINGE
SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008 NDA Novartis Pharmaceuticals Corporation 0078-0647 0078-0647-81 1 VIAL, SINGLE-USE in 1 KIT (0078-0647-81) > 1 KIT in 1 VIAL, SINGLE-USE (0078-0647-61) * 6 mL in 1 VIAL, SINGLE-USE * 2 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/VIAL
Approval Date:Nov 25, 1998TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jan 13, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent 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:Yes
Patent:► SubscribePatent Expiration:Jan 13, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021008

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-002Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-002Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-001Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-002Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-003Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-003Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-003Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-003Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-001Nov 25, 1998► Subscribe► Subscribe
NovartisSANDOSTATIN LARoctreotide acetateINJECTABLE;INJECTION021008-003Nov 25, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Teva
Chubb
Cerilliant
Fuji
Medtronic
Covington
Chinese Patent Office
Farmers Insurance
US Department of Justice
Express Scripts

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