Details for New Drug Application (NDA): 070172
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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 070172
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Hospira |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070172
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 070172
Suppliers and Packaging for NDA: 070172
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070172 | ANDA | Henry Schein, Inc. | 0404-9920 | 0404-9920-01 | 1 BOX in 1 BAG (0404-9920-01) / 1 CARTRIDGE in 1 BOX / 1 mL in 1 CARTRIDGE |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070172 | ANDA | Hospira, Inc. | 0409-1782 | 0409-1782-69 | 10 CARTRIDGE in 1 BOX (0409-1782-69) / 1 mL in 1 CARTRIDGE (0409-1782-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
Approval Date: | Sep 24, 1986 | TE: | AP | RLD: | No |
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