Details for New Drug Application (NDA): 216977
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NDA 216977 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.
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 216977
| Tradename: | NALOXONE HYDROCHLORIDE |
| Applicant: | Bpi Labs |
| Ingredient: | naloxone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216977
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 216977
Suppliers and Packaging for NDA: 216977
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 216977 | ANDA | BPI Labs LLC | 54288-124 | 54288-124-01 | 1 PACKAGE in 1 CARTON (54288-124-01) / 2 mL in 1 PACKAGE |
| NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 216977 | ANDA | BPI Labs LLC | 54288-124 | 54288-124-10 | 10 PACKAGE in 1 CARTON (54288-124-10) / 2 mL in 1 PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Oct 6, 2023 | TE: | AP | RLD: | No | ||||
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