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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063000

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NDA 063000 describes POLYMYXIN B SULFATE, which is a drug marketed by X Gen Pharms, West-ward Pharms Int, Gland Pharma Ltd, Paddock Llc, Xellia Pharms Aps, Fresenius Kabi Usa, and Aurobindo Pharma Ltd, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the POLYMYXIN B SULFATE profile page.

The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.

Summary for NDA: 063000

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 063000

Ingredient-typePolymyxins

Suppliers and Packaging for NDA: 063000

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYMYXIN B SULFATE
polymyxin b sulfate
INJECTABLE;INJECTION 063000 ANDA X-GEN Pharmaceuticals, Inc. 39822-0166 39822-0166-5 1 VIAL in 1 CARTON (39822-0166-5) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
POLYMYXIN B SULFATE
polymyxin b sulfate
INJECTABLE;INJECTION 063000 ANDA X-GEN Pharmaceuticals, Inc. 39822-0166 39822-0166-7 1 VIAL in 1 CARTON (39822-0166-7) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500,000 UNITS BASE/VIAL
Approval Date:Sep 30, 1994TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Deloitte
Novartis
Fish and Richardson
Johnson and Johnson
Cantor Fitzgerald
Chubb
Express Scripts
Queensland Health
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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