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Serving 500+ biopharmaceutical companies globally:

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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078066

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NDA 078066 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 fifteen 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-two suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

Summary for NDA: 078066

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

Pharmacology for NDA: 078066

Ingredient-typeCholecalciferol

Suppliers and Packaging for NDA: 078066

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL
calcitriol
INJECTABLE;INJECTION 078066 ANDA Akorn, Inc. 17478-831 17478-831-01 10 AMPULE in 1 CARTON (17478-831-01) > 1 mL in 1 AMPULE
CALCITRIOL
calcitriol
INJECTABLE;INJECTION 078066 ANDA Akorn, Inc. 17478-931 17478-931-01 10 AMPULE in 1 CARTON (17478-931-01) > 1 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.001MG/ML
Approval Date:Jan 29, 2008TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.002MG/ML
Approval Date:Jan 29, 2008TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Federal Trade Commission
Cipla
AstraZeneca
Teva
McKesson
Julphar
US Department of Justice
QuintilesIMS
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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