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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 090834


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NDA 090834 describes OCTREOTIDE ACETATE (PRESERVATIVE FREE), which is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, and West-ward Pharms Int, and is included in four NDAs. It is available from four suppliers. Additional details are available on the OCTREOTIDE ACETATE (PRESERVATIVE FREE) profile page.

The generic ingredient in OCTREOTIDE ACETATE (PRESERVATIVE FREE) is octreotide acetate. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 090834
Tradename:OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Applicant:Sagent Pharms Inc
Ingredient:octreotide acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090834
Medical Subject Heading (MeSH) Categories for 090834
Suppliers and Packaging for NDA: 090834
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 090834 ANDA Sagent Pharmaceuticals 25021-451 25021-451-01 10 VIAL in 1 CARTON (25021-451-01) > 1 mL in 1 VIAL
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 090834 ANDA Sagent Pharmaceuticals 25021-452 25021-452-01 10 VIAL in 1 CARTON (25021-452-01) > 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Nov 12, 2013TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML
Approval Date:Nov 12, 2013TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Nov 12, 2013TE:APRLD:No

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