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Details for New Drug Application (NDA): 090986

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NDA 090986 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 seventeen 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: 090986

Tradename:
OCTREOTIDE ACETATE
Applicant:
Wockhardt Usa
Ingredient:
octreotide acetate
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 0.2MG BASE/ML
Approval Date:May 11, 2011TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:May 11, 2011TE:RLD:No


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