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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 217992


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NDA 217992 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-five 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 217992
Tradename:NALOXONE HYDROCHLORIDE
Applicant:Amneal
Ingredient:naloxone hydrochloride
Patents:0
Pharmacology for NDA: 217992
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 217992
Suppliers and Packaging for NDA: 217992
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE HYDROCHLORIDE naloxone hydrochloride SPRAY, METERED;NASAL 217992 ANDA Walgreen Co. 0363-2140 0363-2140-02 2 VIAL in 1 CARTON (0363-2140-02) / .1 mL in 1 VIAL (0363-2140-01)
NALOXONE HYDROCHLORIDE naloxone hydrochloride SPRAY, METERED;NASAL 217992 ANDA AvKARE 42291-493 42291-493-02 2 VIAL, SINGLE-DOSE in 1 CARTON (42291-493-02) / .1 mL in 1 VIAL, SINGLE-DOSE (42291-493-01)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SPRAY, METERED;NASALStrength4MG/SPRAY
Approval Date:Apr 23, 2024TE:RLD:No

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