Details for New Drug Application (NDA): 205014
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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 205014
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Mylan Institutional |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205014
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 205014
Suppliers and Packaging for NDA: 205014
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 205014 | ANDA | Mylan Institutional LLC | 67457-299 | 67457-299-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (67457-299-10) / 10 mL in 1 VIAL, MULTI-DOSE (67457-299-00) |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 205014 | ANDA | Mylan Institutional LLC | 67457-987 | 67457-987-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (67457-987-10) / 10 mL in 1 VIAL, MULTI-DOSE (67457-987-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
Approval Date: | Jun 29, 2016 | TE: | AP | RLD: | No |
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