01 7BUPRENORPHINE HYDROCHLORIDE
02 3BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
03 1NALDEMEDINE TOSYLATE
04 5OXYCODONE
05 9TAPENTADOL HYDROCHLORIDE
01 11BDSI
02 14COLLEGIUM PHARM INC
01 5CAPSULE, EXTENDED RELEASE;ORAL
02 10FILM;BUCCAL
03 1SOLUTION;ORAL
04 5TABLET, EXTENDED RELEASE;ORAL
05 4TABLET;ORAL
01 113.5MG
02 118MG
03 127MG
04 136MG
05 19MG
06 1EQ 0.075MG BASE
07 1EQ 0.15MG BASE
08 1EQ 0.2MG BASE
09 1EQ 0.3MG BASE
10 1EQ 0.45MG BASE
11 1EQ 0.6MG BASE
12 1EQ 0.75MG BASE
13 1EQ 0.9MG BASE
14 2EQ 100MG BASE
15 1EQ 150MG BASE
16 1EQ 2.1MG BASE;EQ 0.3MG BASE
17 1EQ 200MG BASE
18 1EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
19 1EQ 250MG BASE
20 1EQ 4.2MG BASE;EQ 0.7MG BASE
21 2EQ 50MG BASE
22 1EQ 6.3MG BASE;EQ 1MG BASE
23 1EQ 75MG BASE
01 25USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FILM;BUCCAL
Brand Name : BELBUCA
Dosage Strength : EQ 0.075MG BASE
Packaging :
Approval Date : 2015-10-23
Application Number : 207932
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FILM;BUCCAL
Brand Name : BELBUCA
Dosage Strength : EQ 0.15MG BASE
Packaging :
Approval Date : 2015-10-23
Application Number : 207932
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FILM;BUCCAL
Brand Name : BELBUCA
Dosage Strength : EQ 0.3MG BASE
Packaging :
Approval Date : 2015-10-23
Application Number : 207932
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FILM;BUCCAL
Brand Name : BELBUCA
Dosage Strength : EQ 0.45MG BASE
Packaging :
Approval Date : 2015-10-23
Application Number : 207932
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FILM;BUCCAL
Brand Name : BELBUCA
Dosage Strength : EQ 0.6MG BASE
Packaging :
Approval Date : 2015-10-23
Application Number : 207932
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FILM;BUCCAL
Brand Name : BELBUCA
Dosage Strength : EQ 0.75MG BASE
Packaging :
Approval Date : 2015-10-23
Application Number : 207932
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FILM;BUCCAL
Brand Name : BELBUCA
Dosage Strength : EQ 0.9MG BASE
Packaging :
Approval Date : 2015-10-23
Application Number : 207932
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Dosage Form : FILM;BUCCAL
Brand Name : BUNAVAIL
Dosage Strength : EQ 2.1MG BASE;EQ 0.3MG...
Packaging :
Approval Date : 2014-06-06
Application Number : 205637
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Dosage Form : FILM;BUCCAL
Brand Name : BUNAVAIL
Dosage Strength : EQ 4.2MG BASE;EQ 0.7MG...
Packaging :
Approval Date : 2014-06-06
Application Number : 205637
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Dosage Form : FILM;BUCCAL
Brand Name : BUNAVAIL
Dosage Strength : EQ 6.3MG BASE;EQ 1MG B...
Packaging :
Approval Date : 2014-06-06
Application Number : 205637
Regulatory Info : DISCN
Registration Country : USA
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