FDA ANDA 210317, OCTREOTIDE ACETATE, TEVA PHARMS USA INC, 12/05/2023

FDA ANDA 210317, OCTREOTIDE ACETATE, TEVA PHARMS USA INC, 12/05/2023

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Contents: Summary Basis of Approval and related FDA review documents for ANDA 210317 for OCTREOTIDE ACETATE approved on 12/5/2023.

ANDA: 210317
Company: TEVA PHARMS USA INC
Drug Name: OCTREOTIDE ACETATE
Active Ingredients: OCTREOTIDE ACETATE
Strength: EQ 30MG BASE/VIAL
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 12/05/2023
Marketing Status: Prescription
Submission Classification: ORIG-1
Action Date: AB

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