Details for New Drug Application (NDA): 207490
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The generic ingredient in BUPRENORPHINE 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 207490
Tradename: | BUPRENORPHINE |
Applicant: | Alvogen |
Ingredient: | buprenorphine |
Patents: | 0 |
Pharmacology for NDA: 207490
Mechanism of Action | Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 207490
Suppliers and Packaging for NDA: 207490
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPRENORPHINE | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 207490 | ANDA | Alvogen Inc. | 47781-406 | 47781-406-04 | 4 POUCH in 1 CARTON (47781-406-04) / 1 PATCH in 1 POUCH (47781-406-11) / 168 h in 1 PATCH |
BUPRENORPHINE | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 207490 | ANDA | Alvogen Inc. | 47781-407 | 47781-407-04 | 4 POUCH in 1 CARTON (47781-407-04) / 1 PATCH in 1 POUCH (47781-407-11) / 168 h in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 5MCG/HR | ||||
Approval Date: | May 17, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 10MCG/HR | ||||
Approval Date: | May 17, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 15MCG/HR | ||||
Approval Date: | May 17, 2022 | TE: | AB | RLD: | No |
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