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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 203289

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NDA 203289 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 sixteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 203289
Applicant:Amneal Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 203289
Medical Subject Heading (MeSH) Categories for 203289
Suppliers and Packaging for NDA: 203289
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL calcitriol CAPSULE;ORAL 203289 ANDA Amneal Pharmaceuticals LLC 65162-519 65162-519-03 30 CAPSULE in 1 BOTTLE (65162-519-03)
CALCITRIOL calcitriol CAPSULE;ORAL 203289 ANDA Amneal Pharmaceuticals LLC 65162-519 65162-519-10 100 CAPSULE in 1 BOTTLE (65162-519-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Jun 14, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MCG
Approval Date:Jun 14, 2017TE:ABRLD:No

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