Details for New Drug Application (NDA): 209522
✉ 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 209522
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Teva Pharms Usa |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209522
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 209522
Suppliers and Packaging for NDA: 209522
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | SPRAY, METERED;NASAL | 209522 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-2165 | 0093-2165-68 | 2 BLISTER PACK in 1 CARTON (0093-2165-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0093-2165-19) / .1 mL in 1 VIAL, SINGLE-DOSE |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | SPRAY, METERED;NASAL | 209522 | ANDA | Actavis Pharma, Inc. | 0591-2971 | 0591-2971-99 | 2 BLISTER PACK in 1 CARTON (0591-2971-99) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-2971-54) / .1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 4MG/SPRAY | ||||
Approval Date: | Apr 19, 2019 | TE: | RLD: | No |
Complete Access Available with Subscription