You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 211003


✉ Email this page to a colleague

« Back to Dashboard


NDA 211003 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Amneal, Hikma, Meitheal, Ailex Pharms Llc, Gland Pharma Ltd, Hainan Poly Pharm, Mylan Teoranta, Novast Labs, and Sandoz, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the LEVOLEUCOVORIN CALCIUM profile page.

The generic ingredient in LEVOLEUCOVORIN CALCIUM is levoleucovorin calcium. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for 211003
Tradename:LEVOLEUCOVORIN CALCIUM
Applicant:Meitheal
Ingredient:levoleucovorin calcium
Patents:0
Pharmacology for NDA: 211003
Medical Subject Heading (MeSH) Categories for 211003
Suppliers and Packaging for NDA: 211003
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 211003 ANDA Meitheal Pharmaceuticals Inc 71288-104 71288-104-10 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-104-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 50MG BASE/VIAL
Approval Date:Aug 22, 2019TE:APRLD: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.