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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

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. Eight 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
Medical Subject Heading (MeSH) Categories for 019667
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)
Paragraph IV (Patent) Challenges for 019667
Tradename Dosage Ingredient NDA Submissiondate
SANDOSTATIN INJECTABLE;INJECTION octreotide acetate 019667 2008-01-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Oct 21, 1988TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML
Approval Date:Oct 21, 1988TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Oct 21, 1988TE:APRLD:Yes

Expired US Patents for NDA 019667

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

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