Details for New Drug Application (NDA): 212300
✉ Email this page to a colleague
NDA 212300 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 eleven 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.
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 212300
| Tradename: | NALOXONE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | naloxone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212300
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 212300
Suppliers and Packaging for NDA: 212300
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 212300 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6205 | 0641-6205-10 | 10 SYRINGE in 1 CARTON (0641-6205-10) / 2 mL in 1 SYRINGE (0641-6205-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Jun 10, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
| Approval Date: | Mar 7, 2024 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
