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Generated: July 28, 2017

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

The generic ingredient in SANDOSTATIN 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 NDA: 019667

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 019667

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
SANDOSTATIN
octreotide acetate
INJECTABLE;INJECTION019667-004Jun 12, 1991► Subscribe► Subscribe
Novartis
SANDOSTATIN
octreotide acetate
INJECTABLE;INJECTION019667-005Jun 12, 1991► Subscribe► Subscribe
Novartis
SANDOSTATIN
octreotide acetate
INJECTABLE;INJECTION019667-001Oct 21, 1988► Subscribe► Subscribe
Novartis
SANDOSTATIN
octreotide acetate
INJECTABLE;INJECTION019667-002Oct 21, 1988► Subscribe► Subscribe
Novartis
SANDOSTATIN
octreotide acetate
INJECTABLE;INJECTION019667-003Oct 21, 1988► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Fuji
Merck
Johnson and Johnson
Cipla
Deloitte
Moodys
Healthtrust
McKesson
Daiichi Sankyo
Cerilliant

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