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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076313

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NDA 076313 describes OCTREOTIDE ACETATE (PRESERVATIVE FREE), which is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms, 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. Nine suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 076313
Tradename:OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Applicant:West-ward Pharms Int
Ingredient:octreotide acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076313
Medical Subject Heading (MeSH) Categories for 076313
Suppliers and Packaging for NDA: 076313
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 076313 ANDA West-Ward Pharmaceuticals Corp. 0641-6174 0641-6174-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6174-10) > 1 mL in 1 VIAL, SINGLE-DOSE (0641-6174-01)
OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 076313 ANDA West-Ward Pharmaceuticals Corp. 0641-6175 0641-6175-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6175-10) > 1 mL in 1 VIAL, SINGLE-DOSE (0641-6175-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Mar 28, 2005TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Mar 28, 2005TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML
Approval Date:Mar 28, 2005TE:APRLD:No

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