Details for New Drug Application (NDA): 212300
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, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Ph Health, Rising, Smith And Nephew, Solopak, Somerset Theraps Llc, Sterinova Inc, Watson Labs, Amneal, Padagis Israel, Teva Pharms Usa, Kaleo Inc, Lupin, and Sun Pharm Inds Ltd, and is included in seventy-one NDAs. It is available from forty suppliers. There are six 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 two 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 two 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. | 0641-6193 | 0641-6193-10 | 10 SYRINGE in 1 CARTON (0641-6193-10) / 1 mL in 1 SYRINGE (0641-6193-01) |
| 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 | ||||
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