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Approved Drug Products containing 22410 listed in the FDA Orange Book. Original Data : FDA Website

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01 INDIVIOR (4)

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01 FILM;BUCCAL, SUBLINGUAL (4)

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01 RX (4)

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01 SUBOXONE (4)

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01 Yes (4)

URL Supplier Web Content
FILM; BUCCAL, SUBL...
EQ 8MG BASE;EQ 2MG...
2010-08-30
22410
SUBOXONE
RX
Yes
AB
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URL Supplier Web Content
FILM; BUCCAL, SUBL...
EQ 4MG BASE;EQ 1MG...
2012-08-10
22410
SUBOXONE
RX
Yes
AB
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URL Supplier Web Content
FILM; BUCCAL, SUBL...
EQ 2MG BASE;EQ 0.5...
2010-08-30
22410
SUBOXONE
RX
Yes
AB
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PHARMACOMPASS
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URL Supplier Web Content
FILM; BUCCAL, SUBL...
EQ 12MG BASE;EQ 3M...
2012-08-10
22410
SUBOXONE
RX
Yes
AB
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PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for FDA Orange Book APPLICATION 22410

Looking for FDA Orange Book APPLICATION 22410 4

19

Indivior, based in U.S.A, is a pharmaceutical company.

One of their notable products is BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE, with a corresponding application number 22410.

Regulatory Information RX

With a dosage strength EQ 8MG BASE;EQ 2MG BASE

Dosage Form Route FILM; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2010-08-30

Therapeutic Equivalence (TE) Code AB

18

Indivior, based in U.S.A, is a pharmaceutical company.

One of their notable products is BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE, with a corresponding application number 22410.

Regulatory Information RX

With a dosage strength EQ 4MG BASE;EQ 1MG BASE

Dosage Form Route FILM; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-08-10

Therapeutic Equivalence (TE) Code AB

17

Indivior, based in U.S.A, is a pharmaceutical company.

One of their notable products is BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE, with a corresponding application number 22410.

Regulatory Information RX

With a dosage strength EQ 2MG BASE;EQ 0.5MG BASE

Dosage Form Route FILM; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2010-08-30

Therapeutic Equivalence (TE) Code AB

16

Indivior, based in U.S.A, is a pharmaceutical company.

One of their notable products is BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE, with a corresponding application number 22410.

Regulatory Information RX

With a dosage strength EQ 12MG BASE;EQ 3MG BASE

Dosage Form Route FILM; BUCCAL, SUBLINGUAL

Reference Listed Drug Yes

Approved since 2012-08-10

Therapeutic Equivalence (TE) Code AB

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