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Queensland Health
Argus Health

Generated: May 25, 2018

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
Applicant:West-ward Pharms Int
Formulation / Manufacturing:see details
Pharmacology for NDA: 076917
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 N 0054-0007-13
CALCITRIOL calcitriol CAPSULE;ORAL 076917 ANDA West-Ward Pharmaceuticals Corp. 0054-0007 N 0054-0007-25

Profile for product number 001

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

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Fish and Richardson
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US Army
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