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Serving leading biopharmaceutical companies globally:

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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078520

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NDA 078520 describes PAMIDRONATE DISODIUM, which is a drug marketed by Aesgen, Areva Pharms, Fresenius Kabi Usa, Hospira, Luitpold, Mn Pharms, Mylan Labs Ltd, Pliva Lachema, Sagent Pharms, Sun Pharma Global, Teva Pharms Usa, and West-ward Pharms Int, and is included in fourteen NDAs. It is available from seven suppliers. Additional details are available on the PAMIDRONATE DISODIUM profile page.

The generic ingredient in PAMIDRONATE DISODIUM is pamidronate disodium. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pamidronate disodium profile page.

Summary for 078520

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078520

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 078520

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 078520 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0107 0069-0107-01 10 mL in 1 VIAL (0069-0107-01)
PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 078520 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0109 0069-0109-01 10 mL in 1 VIAL (0069-0109-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/10ML (3MG/ML)
Approval Date:Oct 31, 2008TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength90MG/10ML (9MG/ML)
Approval Date:Oct 31, 2008TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

McKesson
Fish and Richardson
McKinsey
Citi
AstraZeneca
Teva
Daiichi Sankyo
Covington
Merck
Moodys

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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