Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021008

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SANDOSTATIN LAR (OCTREOTIDE ACETATE)
EQ 10MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: SANDOSTATIN LAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021008
Product Number: 001
Approval Date: Nov 25, 1998
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

SANDOSTATIN LAR (OCTREOTIDE ACETATE)
EQ 20MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: SANDOSTATIN LAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021008
Product Number: 002
Approval Date: Nov 25, 1998
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

SANDOSTATIN LAR (OCTREOTIDE ACETATE)
EQ 30MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: SANDOSTATIN LAR
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 30MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021008
Product Number: 003
Approval Date: Nov 25, 1998
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information