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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 091174


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NDA 091174 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma, Hikma, Strides Pharma, Sun Pharm, Teva, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Anda Repository, and Rising, and is included in eighteen NDAs. It is available from twenty 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 091174
Tradename:CALCITRIOL
Applicant:Bionpharma
Ingredient:calcitriol
Patents:0
Pharmacology for NDA: 091174
Medical Subject Heading (MeSH) Categories for 091174
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 Aphena Pharma Solutions - Tennessee, LLC 43353-998 43353-998-09 9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-998-09)
CALCITRIOL calcitriol CAPSULE;ORAL 091174 ANDA A-S Medication Solutions 50090-6711 50090-6711-0 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-6711-0)

Profile for product number 001

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

Profile for product number 002

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

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