Details for New Drug Application (NDA): 076931
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The generic ingredient in BUPRENORPHINE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 076931
Tradename: | BUPRENORPHINE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | buprenorphine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076931
Mechanism of Action | Partial Opioid Agonists |
Suppliers and Packaging for NDA: 076931
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | INJECTABLE;INJECTION | 076931 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9246 | 0143-9246-05 | 5 VIAL in 1 CARTON (0143-9246-05) / 1 mL in 1 VIAL (0143-9246-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.3MG BASE/ML | ||||
Approval Date: | Mar 2, 2005 | TE: | AP | RLD: | No |
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