Details for New Drug Application (NDA): 021306
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The generic ingredient in BUTRANS is buprenorphine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 021306
Tradename: | BUTRANS |
Applicant: | Purdue Pharma Lp |
Ingredient: | buprenorphine |
Patents: | 0 |
Pharmacology for NDA: 021306
Mechanism of Action | Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 021306
Suppliers and Packaging for NDA: 021306
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306 | NDA AUTHORIZED GENERIC | Rhodes Pharmaceuticals L.P. | 42858-353 | 42858-353-40 | 4 POUCH in 1 CARTON (42858-353-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH |
BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306 | NDA AUTHORIZED GENERIC | Rhodes Pharmaceuticals L.P. | 42858-493 | 42858-493-40 | 4 POUCH in 1 CARTON (42858-493-40) / 1 PATCH in 1 POUCH / 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: | Jun 30, 2010 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 10MCG/HR | ||||
Approval Date: | Jun 30, 2010 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 20MCG/HR | ||||
Approval Date: | Jun 30, 2010 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021306
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-003 | Jun 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-001 | Jun 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-003 | Jun 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-004 | Jul 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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