01 7BUPRENORPHINE HYDROCHLORIDE
02 3BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
03 1NALDEMEDINE TOSYLATE
01 11BDSI
01 10FILM;BUCCAL
02 1TABLET;ORAL
01 1EQ 0.075MG BASE
02 1EQ 0.15MG BASE
03 1EQ 0.2MG BASE
04 1EQ 0.3MG BASE
05 1EQ 0.45MG BASE
06 1EQ 0.6MG BASE
07 1EQ 0.75MG BASE
08 1EQ 0.9MG BASE
09 1EQ 2.1MG BASE;EQ 0.3MG BASE
10 1EQ 4.2MG BASE;EQ 0.7MG BASE
11 1EQ 6.3MG BASE;EQ 1MG BASE
01 11USA
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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