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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075959

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NDA 075959 describes OCTREOTIDE ACETATE, which is a drug marketed by Sun Pharm Inds, West-ward Pharms Int, Sagent Pharms, Fresenius Kabi Usa, Teva Pharms Usa, 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 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 NDA: 075959

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 075959

Suppliers and Packaging for NDA: 075959

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION 075959 ANDA Teva Parenteral Medicines, Inc. 0703-3333 0703-3333-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3333-01) > 5 mL in 1 VIAL, MULTI-DOSE
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION 075959 ANDA Teva Parenteral Medicines, Inc. 0703-3343 0703-3343-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3343-01) > 5 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.2MG BASE/ML
Approval Date:Nov 21, 2005TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Nov 21, 2005TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Accenture
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Fuji
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