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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Teva
Boehringer Ingelheim
Fuji
US Department of Justice
Chubb
Daiichi Sankyo
Cantor Fitzgerald
Medtronic
McKesson

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076917

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NDA 076917 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma Inc, Strides Pharma, Teva, West-ward Pharms Int, Akorn, Fresenius Kabi Usa, Fresenius Medcl, Hospira, Luitpold, Rockwell Medcl, Sagent Pharms, and Teva Parenteral, and is included in fourteen NDAs. It is available from fourteen 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-one suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

Summary for 076917

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076917

Ingredient-typeCholecalciferol

Medical Subject Heading (MeSH) Categories for 076917

Suppliers and Packaging for NDA: 076917

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL calcitriol CAPSULE;ORAL 076917 ANDA West-Ward Pharmaceuticals Corp. 0054-0007 0054-0007-25 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-25)
CALCITRIOL calcitriol CAPSULE;ORAL 076917 ANDA West-Ward Pharmaceuticals Corp. 0054-0007 0054-0007-13 30 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MCG
Approval Date:Mar 27, 2006TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
US Army
Farmers Insurance
Deloitte
Cantor Fitzgerald
Cerilliant
Dow
Healthtrust
Merck

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