Details for New Drug Application (NDA): 201760
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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 201760
Tradename: | BUPRENORPHINE HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | buprenorphine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201760
Mechanism of Action | Partial Opioid Agonists |
Suppliers and Packaging for NDA: 201760
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 201760 | ANDA | AvPAK | 50268-128 | 50268-128-15 | 50 BLISTER PACK in 1 BOX (50268-128-15) / 1 TABLET in 1 BLISTER PACK (50268-128-11) |
BUPRENORPHINE HYDROCHLORIDE | buprenorphine hydrochloride | TABLET;SUBLINGUAL | 201760 | ANDA | AvPAK | 50268-129 | 50268-129-15 | 50 BLISTER PACK in 1 BOX (50268-129-15) / 1 TABLET in 1 BLISTER PACK (50268-129-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Jan 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 8MG BASE | ||||
Approval Date: | Jan 29, 2016 | TE: | AB | RLD: | No |
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