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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077450

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NDA 077450 describes OCTREOTIDE ACETATE, which is a drug marketed by Fresenius Kabi Usa, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, and Mylan Institutional, and is included in sixteen NDAs. It is available from six suppliers. Additional details are available on the OCTREOTIDE ACETATE profile page.

The generic ingredient in OCTREOTIDE ACETATE is octreotide acetate. There are nineteen 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 077450
Tradename:OCTREOTIDE ACETATE
Applicant:Fresenius Kabi Usa
Ingredient:octreotide acetate
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Pharmacology for NDA: 077450
Medical Subject Heading (MeSH) Categories for 077450
Suppliers and Packaging for NDA: 077450
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077450 ANDA Fresenius Kabi USA, LLC 63323-378 63323-378-05 1 VIAL, MULTI-DOSE in 1 CARTON (63323-378-05) > 5 mL in 1 VIAL, MULTI-DOSE
OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077450 ANDA Fresenius Kabi USA, LLC 63323-379 63323-379-05 1 VIAL, MULTI-DOSE in 1 CARTON (63323-379-05) > 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.2MG BASE/ML
Approval Date:Feb 10, 2006TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Feb 10, 2006TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Covington
Fuji
Boehringer Ingelheim
Accenture
Federal Trade Commission
Mallinckrodt
Cerilliant
Daiichi Sankyo

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