Details for New Drug Application (NDA): 070257
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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 070257
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Hospira |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 070257
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 070257
Suppliers and Packaging for NDA: 070257
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070257 | ANDA | Hospira, Inc. | 0409-1219 | 0409-1219-01 | 25 CARTON in 1 CASE (0409-1219-01) / 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE (0409-1219-41) |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070257 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1385 | 51662-1385-1 | 1 VIAL, MULTI-DOSE in 1 CARTON (51662-1385-1) / 10 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
Approval Date: | Jan 7, 1987 | TE: | AP | RLD: | No |
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