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Last Updated: July 15, 2020

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Details for New Drug Application (NDA): 078066

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NDA 078066 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma Inc, Hikma, Strides Pharma, Sun Pharm, Teva, Akorn, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Rockwell Medcl, Sagent Pharms, Teva Parenteral, and Elysium, and is included in seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 078066
Tradename:CALCITRIOL
Applicant:Akorn
Ingredient:calcitriol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078066
Medical Subject Heading (MeSH) Categories for 078066
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

Profile for product number 001

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

Profile for product number 002

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

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