Details for New Drug Application (NDA): 207634
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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 207634
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Somerset Theraps Llc |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207634
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 207634
Suppliers and Packaging for NDA: 207634
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 207634 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1426 | 51662-1426-1 | 1 VIAL, GLASS in 1 CARTON (51662-1426-1) / 10 mL in 1 VIAL, GLASS |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 207634 | ANDA | Somerset Therapeutics, LLC | 70069-072 | 70069-072-10 | 10 CARTON in 1 BOX (70069-072-10) / 1 VIAL, GLASS in 1 CARTON (70069-072-01) / 10 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
Approval Date: | Jul 26, 2017 | TE: | AP | RLD: | No |
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