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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019667

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SANDOSTATIN (OCTREOTIDE ACETATE)
EQ 0.05MG BASE/ML
Marketing Status: Prescription
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: SANDOSTATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.05MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019667
Product Number: 001
Approval Date: Oct 21, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
SANDOSTATIN (OCTREOTIDE ACETATE)
EQ 0.1MG BASE/ML
Marketing Status: Prescription
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: SANDOSTATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.1MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019667
Product Number: 002
Approval Date: Oct 21, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
SANDOSTATIN (OCTREOTIDE ACETATE)
EQ 0.5MG BASE/ML
Marketing Status: Prescription
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: SANDOSTATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019667
Product Number: 003
Approval Date: Oct 21, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
SANDOSTATIN (OCTREOTIDE ACETATE)
EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: SANDOSTATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019667
Product Number: 004
Approval Date: Jun 12, 1991
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
SANDOSTATIN (OCTREOTIDE ACETATE)
EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: SANDOSTATIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019667
Product Number: 005
Approval Date: Jun 12, 1991
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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