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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 203973


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NDA 203973 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 203973
Tradename:CALCITRIOL
Applicant:Anda Repository
Ingredient:calcitriol
Patents:0
Pharmacology for NDA: 203973
Medical Subject Heading (MeSH) Categories for 203973
Suppliers and Packaging for NDA: 203973
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL calcitriol SOLUTION;ORAL 203973 ANDA Patrin Pharma, Inc 39328-042 39328-042-15 1 BOTTLE, GLASS in 1 CARTON (39328-042-15) / 15 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MCG/ML
Approval Date:Jul 28, 2023TE:AARLD:No

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