Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210317

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

Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: OCTREOTIDE ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210317
Product Number: 001
Approval Date: Dec 5, 2023
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: OCTREOTIDE ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210317
Product Number: 002
Approval Date: Dec 5, 2023
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: OCTREOTIDE ACETATE
Proprietary Name: OCTREOTIDE ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 30MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210317
Product Number: 003
Approval Date: Dec 5, 2023
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information