Details for New Drug Application (NDA): 201633
✉ Email this page to a colleague
The generic ingredient in BUPRENORPHINE HYDROCHLORIDE AND NALOXONE 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 201633
Tradename: | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201633
Mechanism of Action | Opioid Antagonists Partial Opioid Agonists |
Suppliers and Packaging for NDA: 201633
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 201633 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-969 | 62756-969-64 | 3 BLISTER PACK in 1 CARTON (62756-969-64) / 10 TABLET in 1 BLISTER PACK |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | buprenorphine hydrochloride; naloxone hydrochloride | TABLET;SUBLINGUAL | 201633 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-969 | 62756-969-83 | 30 TABLET in 1 BOTTLE (62756-969-83) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2MG BASE;EQ 0.5MG BASE | ||||
Approval Date: | Aug 5, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 8MG BASE;EQ 2MG BASE | ||||
Approval Date: | Aug 5, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription