Indivior
FDA Approved Drugs

Indivior

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

Discontinued RX
  • Total Records 14
  • Latest Approval Date May 22, 2023
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
14
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Discontinued
7
View
RX
7
View
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Company

Indivior

Country

U.S.A

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Company Snapshot

Indivior

Indivior Inc.North Chesterfield, Virginia, USA

U.S.A

www.indivior.com/en View on Map
FDA Approved Drug Records ( 14 records )
1982
01 Jan
Discontinued Application: 18401

Drug Name

BUPRENEX

Product Number

1

Dosage Form

-

Strength

EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18401 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

18401

Product Number

1

Dosage Form

-

Strength

EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2023
22 May
RX Application: 217470

Drug Name

OPVEE

Product Number

1

Dosage Form

-

Strength

EQ 2.7MG BASE/SPRAY

Approval Date

2023-05-22

217470 / 1

Active Ingredient

NALMEFENE HYDROCHLORIDE

Application Number

217470

Product Number

1

Dosage Form

-

Strength

EQ 2.7MG BASE/SPRAY

Approval Date

2023-05-22

Regulatory Status

RX

2018
27 Jul
Discontinued Application: 210655

Drug Name

PERSERIS KIT

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2018-07-27

210655 / 1

Active Ingredient

RISPERIDONE

Application Number

210655

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2018-07-27

Regulatory Status

Discontinued

2018
27 Jul
Discontinued Application: 210655

Drug Name

PERSERIS KIT

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2018-07-27

210655 / 2

Active Ingredient

RISPERIDONE

Application Number

210655

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2018-07-27

Regulatory Status

Discontinued

2017
30 Nov
RX Application: 209819

Drug Name

SUBLOCADE

Product Number

1

Dosage Form

-

Strength

100MG/0.5ML (100MG/0.5ML)

Approval Date

2017-11-30

209819 / 1

Active Ingredient

BUPRENORPHINE

Application Number

209819

Product Number

1

Dosage Form

-

Strength

100MG/0.5ML (100MG/0.5ML)

Approval Date

2017-11-30

Regulatory Status

RX

2017
30 Nov
RX Application: 209819

Drug Name

SUBLOCADE

Product Number

2

Dosage Form

-

Strength

300MG/1.5ML (200MG/ML)

Approval Date

2017-11-30

209819 / 2

Active Ingredient

BUPRENORPHINE

Application Number

209819

Product Number

2

Dosage Form

-

Strength

300MG/1.5ML (200MG/ML)

Approval Date

2017-11-30

Regulatory Status

RX

2002
08 Oct
Discontinued Application: 20733

Drug Name

SUBOXONE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-10-08

20733 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

20733

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-10-08

Regulatory Status

Discontinued

2002
08 Oct
Discontinued Application: 20733

Drug Name

SUBOXONE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-10-08

20733 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

20733

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-10-08

Regulatory Status

Discontinued

2010
30 Aug
RX Application: 22410

Drug Name

SUBOXONE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2010-08-30

22410 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

22410

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2010-08-30

Regulatory Status

RX

2010
30 Aug
RX Application: 22410

Drug Name

SUBOXONE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2010-08-30

22410 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

22410

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2010-08-30

Regulatory Status

RX

2012
10 Aug
RX Application: 22410

Drug Name

SUBOXONE

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE;EQ 1MG BASE

Approval Date

2012-08-10

22410 / 3

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

22410

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE;EQ 1MG BASE

Approval Date

2012-08-10

Regulatory Status

RX

2012
10 Aug
RX Application: 22410

Drug Name

SUBOXONE

Product Number

4

Dosage Form

-

Strength

EQ 12MG BASE;EQ 3MG BASE

Approval Date

2012-08-10

22410 / 4

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

22410

Product Number

4

Dosage Form

-

Strength

EQ 12MG BASE;EQ 3MG BASE

Approval Date

2012-08-10

Regulatory Status

RX

2002
08 Oct
Discontinued Application: 20732

Drug Name

SUBUTEX

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-10-08

20732 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

20732

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-10-08

Regulatory Status

Discontinued

2002
08 Oct
Discontinued Application: 20732

Drug Name

SUBUTEX

Product Number

3

Dosage Form

-

Strength

EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-10-08

20732 / 3

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

20732

Product Number

3

Dosage Form

-

Strength

EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-10-08

Regulatory Status

Discontinued

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Drug Status Breakdown
14 total
  • Discontinued
  • RX
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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Explore important FDA approved drug information available in the records above.

Drug Name

BUPRENEX

Application Number

18401

Product Number

1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Dosage Form

-

Strength

EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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