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Serving 500+ biopharmaceutical companies globally:

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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075836

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NDA 075836 describes CALCITRIOL, which is a drug marketed by Sagent Pharms, Rockwell Medcl, Hospira, West-ward Pharms Int, Teva Parenteral, Fresenius Kabi Usa, Luitpold, Strides Pharma, Teva, Akorn, Fresenius Medcl, Bionpharma Inc, and Amneal Pharms, and is included in fourteen NDAs. It is available from seventeen suppliers. Additional details are available on the CALCITRIOL profile page.

The generic ingredient in CALCITRIOL is calcitriol. There are ten drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

Summary for NDA: 075836

Formulation / Manufacturing:see details

Pharmacology for NDA: 075836


Suppliers and Packaging for NDA: 075836

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 075836 ANDA Fresenius Kabi USA, LLC 63323-731 63323-731-01 5 TRAY in 1 CARTON (63323-731-01) > 10 AMPULE in 1 TRAY > 1 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.001MG/ML
Approval Date:Dec 31, 2002TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.002MG/ML
Approval Date:Dec 31, 2002TE:RLD:No

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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Fish and Richardson
Farmers Insurance
Cantor Fitzgerald

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