Details for New Drug Application (NDA): 214785
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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 214785
Tradename: | NALOXONE HYDROCHLORIDE |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 214785
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 214785
Suppliers and Packaging for NDA: 214785
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 214785 | ANDA | Baxter Healthcare Corporation | 36000-308 | 36000-308-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-308-10) / 1 mL in 1 VIAL, SINGLE-DOSE (36000-308-01) |
NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 214785 | ANDA | Medical Purchasing Solutions, LLC | 71872-7297 | 71872-7297-1 | 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7297-1) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
Approval Date: | Jan 29, 2021 | TE: | AP | RLD: | No |
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