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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Generated: November 22, 2017

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 West-ward Pharms Int, Sagent Pharms, Fresenius Kabi Usa, and Mylan Institutional, 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 eighteen 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:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
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)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Moodys

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