Details for New Drug Application (NDA): 070256
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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 070256
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Hospira |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070256
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 070256
Suppliers and Packaging for NDA: 070256
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070256 | ANDA | Hospira, Inc. | 0409-1215 | 0409-1215-01 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1215-21) |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070256 | ANDA | HF Acquisition Co. LLC, DBA Health First | 51662-1242 | 51662-1242-1 | 1 mL in 1 VIAL (51662-1242-1) |
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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