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

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 214785


✉ Email this page to a colleague

« Back to Dashboard


NDA 214785 describes NALOXONE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Rising, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Amneal, Padagis Israel, Teva Pharms Usa, Kaleo Inc, Lupin, and Sun Pharm Inds Ltd, and is included in sixty-eight NDAs. It is available from thirty-six suppliers. There are eighteen patents protecting this drug. Additional details are available on the NALOXONE HYDROCHLORIDE profile page.

The generic ingredient in NALOXONE HYDROCHLORIDE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.
Summary for 214785
Tradename:NALOXONE HYDROCHLORIDE
Applicant:Baxter Hlthcare Corp
Ingredient:naloxone hydrochloride
Patents:0
Pharmacology for NDA: 214785
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 214785
Suppliers and Packaging for NDA: 214785
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 214785 ANDA Baxter Healthcare Corporation 36000-308 36000-308-10 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-308-10) / 1 mL in 1 VIAL, SINGLE-DOSE (36000-308-01)
NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 214785 ANDA Medical Purchasing Solutions, LLC 71872-7297 71872-7297-1 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7297-1) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:Jan 29, 2021TE: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.