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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Express Scripts
Teva
McKinsey
Cantor Fitzgerald
US Department of Justice
US Army
Cipla

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021160

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NDA 021160 describes PHOSLO GELCAPS, which is a drug marketed by Fresenius Medcl and is included in one NDA. It is available from six suppliers. There are two patents protecting this drug. Additional details are available on the PHOSLO GELCAPS profile page.

The generic ingredient in PHOSLO GELCAPS is calcium acetate. There are two hundred and seventy-five drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
Summary for 021160
Tradename:PHOSLO GELCAPS
Applicant:Fresenius Medcl
Ingredient:calcium acetate
Patents:2
Therapeutic Class:Genitourinary Agents
Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details
Pharmacology for NDA: 021160
Suppliers and Packaging for NDA: 021160
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHOSLO calcium acetate CAPSULE;ORAL 021160 NDA AUTHORIZED GENERIC Sandoz Inc 0781-2081 N 0781-2081-02
PHOSLO calcium acetate CAPSULE;ORAL 021160 NDA AUTHORIZED GENERIC Sandoz Inc 0781-2672 N 0781-2672-02

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength333.5MG
Approval Date:Apr 2, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength667MG
Approval Date:Apr 2, 2001TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Apr 3, 2021Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength667MG
Approval Date:Apr 2, 2001TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 3, 2021Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021160

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Medcl PHOSLO GELCAPS calcium acetate CAPSULE;ORAL 021160-003 Apr 2, 2001 ➤ Sign Up ➤ Sign Up
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-001 Apr 2, 2001 ➤ Sign Up ➤ Sign Up
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-002 Apr 2, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Citi
Colorcon
Baxter
Federal Trade Commission
UBS
Cantor Fitzgerald
Covington
Accenture

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