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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Federal Trade Commission
Argus Health
Queensland Health
Daiichi Sankyo

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090986

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NDA 090986 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 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 090986

Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 090986

Medical Subject Heading (MeSH) Categories for 090986

Suppliers and Packaging for NDA: 090986

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 090986 ANDA Wockhardt Limited 55648-632 55648-632-01 1 VIAL in 1 VIAL (55648-632-01) > 5 mL in 1 VIAL
OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 090986 ANDA Wockhardt Limited 55648-634 55648-634-01 1 VIAL in 1 CARTON (55648-634-01) > 5 mL in 1 VIAL

Summary for product number 001

Approval Date:May 11, 2011TE:RLD:No

Summary for product number 002

Approval Date:May 11, 2011TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Boehringer Ingelheim
US Army
Harvard Business School

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