You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 076242


✉ Email this page to a colleague

« Back to Dashboard


NDA 076242 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 076242
Tradename:CALCITRIOL
Applicant:Hikma
Ingredient:calcitriol
Patents:0
Pharmacology for NDA: 076242
Medical Subject Heading (MeSH) Categories for 076242
Suppliers and Packaging for NDA: 076242
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL calcitriol SOLUTION;ORAL 076242 ANDA Hikma Pharmaceuticals USA Inc. 0054-3120 0054-3120-41 1 BOTTLE, GLASS in 1 CARTON (0054-3120-41) / 15 mL in 1 BOTTLE, GLASS
CALCITRIOL calcitriol SOLUTION;ORAL 076242 ANDA ATLANTIC BIOLOGICALS CORP. 17856-3120 17856-3120-1 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-3120-1) / .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MCG/ML
Approval Date:Jul 18, 2003TE:AARLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.