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Approved Drug Products containing 205637 listed in the FDA Orange Book. Original Data : FDA Website

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01 BDSI (3)

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01 FILM;BUCCAL (3)

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01 DISCN (3)

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01 BUNAVAIL (3)

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01 Yes (3)

URL Supplier Web Content
FILM; BUCCAL
EQ 4.2MG BASE;EQ 0...
2014-06-06
205637
BUNAVAIL
DISCN
Yes
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URL Supplier Web Content
FILM; BUCCAL
EQ 6.3MG BASE;EQ 1...
2014-06-06
205637
BUNAVAIL
DISCN
Yes
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URL Supplier Web Content
FILM; BUCCAL
EQ 2.1MG BASE;EQ 0...
2014-06-06
205637
BUNAVAIL
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 205637

Looking for FDA Orange Book APPLICATION 205637 3

19

BioDelivery Sciences, based in U.S.A, is a pharmaceutical company.

One of their notable products is BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE, with a corresponding application number 205637.

Regulatory Information DISCN

With a dosage strength EQ 4.2MG BASE;EQ 0.7MG BASE

Dosage Form Route FILM; BUCCAL

Reference Listed Drug Yes

Approved since 2014-06-06

18

BioDelivery Sciences, based in U.S.A, is a pharmaceutical company.

One of their notable products is BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE, with a corresponding application number 205637.

Regulatory Information DISCN

With a dosage strength EQ 6.3MG BASE;EQ 1MG BASE

Dosage Form Route FILM; BUCCAL

Reference Listed Drug Yes

Approved since 2014-06-06

17

BioDelivery Sciences, based in U.S.A, is a pharmaceutical company.

One of their notable products is BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE, with a corresponding application number 205637.

Regulatory Information DISCN

With a dosage strength EQ 2.1MG BASE;EQ 0.3MG BASE

Dosage Form Route FILM; BUCCAL

Reference Listed Drug Yes

Approved since 2014-06-06

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