Details for New Drug Application (NDA): 070299
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The generic ingredient in NALOXONE 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 070299
Tradename: | NALOXONE |
Applicant: | Hikma |
Ingredient: | naloxone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 070299
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 070299
Suppliers and Packaging for NDA: 070299
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NALOXONE | naloxone hydrochloride | INJECTABLE;INJECTION | 070299 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6132 | 0641-6132-25 | 25 VIAL in 1 CARTON (0641-6132-25) / 1 mL in 1 VIAL (0641-6132-01) |
NALOXONE | naloxone hydrochloride | INJECTABLE;INJECTION | 070299 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6260 | 0641-6260-25 | 25 VIAL in 1 CARTON (0641-6260-25) / 1 mL in 1 VIAL (0641-6260-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.4MG/ML | ||||
Approval Date: | Sep 24, 1986 | TE: | AP | RLD: | No |
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