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Serving 500+ biopharmaceutical companies globally:

Teva
Federal Trade Commission
Colorcon
AstraZeneca
Dow
US Army
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US Department of Justice
Daiichi Sankyo
Baxter

Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091174

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NDA 091174 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: 091174

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

Pharmacology for NDA: 091174

Ingredient-typeCholecalciferol

Suppliers and Packaging for NDA: 091174

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL
calcitriol
CAPSULE;ORAL 091174 ANDA KAISER FOUNDATION HOSPITALS 0179-0196 0179-0196-70 30 CAPSULE, LIQUID FILLED in 1 BOX, UNIT-DOSE (0179-0196-70)
CALCITRIOL
calcitriol
CAPSULE;ORAL 091174 ANDA KAISER FOUNDATION HOSPITALS 0179-0197 0179-0197-70 30 CAPSULE, LIQUID FILLED in 1 BOX, UNIT-DOSE (0179-0197-70)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MCG
Approval Date:May 24, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:May 24, 2013TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Army
Teva
Queensland Health
McKesson
US Department of Justice
Colorcon
Express Scripts
Moodys
AstraZeneca
Baxter

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