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Details for New Drug Application (NDA): 077457

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NDA 077457 describes OCTREOTIDE ACETATE (PRESERVATIVE FREE), which is a drug marketed by West-ward Pharms Int, Sagent Pharms, Fresenius Kabi Usa, and Mylan Institutional, and is included in four NDAs. It is available from three 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 seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

Summary for NDA: 077457

Tradename:
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Applicant:
Fresenius Kabi Usa
Ingredient:
octreotide acetate
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 077457

Suppliers and Packaging for NDA: 077457

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
octreotide acetate
INJECTABLE;INJECTION 077457 ANDA Fresenius Kabi USA, LLC 63323-365 63323-365-01 10 VIAL, SINGLE-USE in 1 TRAY (63323-365-01) > 1 mL in 1 VIAL, SINGLE-USE
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
octreotide acetate
INJECTABLE;INJECTION 077457 ANDA Fresenius Kabi USA, LLC 63323-365 63323-365-04 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-365-04) > 1 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Feb 10, 2006TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML
Approval Date:Feb 10, 2006TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Feb 10, 2006TE:APRLD:No


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