Details for New Drug Application (NDA): 204997
✉ Email this page to a colleague
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 204997
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Mylan Institutional |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204997
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 204997
Suppliers and Packaging for NDA: 204997
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 204997 | ANDA | A-S Medication Solutions | 50090-6491 | 50090-6491-0 | 10 VIAL, SINGLE-DOSE in 1 CARTON (50090-6491-0) / 1 mL in 1 VIAL, SINGLE-DOSE |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 204997 | ANDA | Mylan Institutional LLC | 67457-292 | 67457-292-02 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-292-02) / 1 mL in 1 VIAL, SINGLE-DOSE (67457-292-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
Approval Date: | Mar 6, 2014 | TE: | AP | RLD: | No |
Complete Access Available with Subscription