Indivior RX
FDA Approved Drugs

Indivior RX

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.

RX
  • Total Records 7
  • Latest Approval Date May 22, 2023
  • Data Source FDA
  • First Approval Date Aug 30, 2010
All
14
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Discontinued
7
View
RX
7
View
Company Overview

Company

Indivior RX

Country

U.S.A

Website

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Company Snapshot

Indivior RX

Indivior Inc.North Chesterfield, Virginia, USA

U.S.A

www.indivior.com/en View on Map
FDA Approved Drug Records ( 7 records )
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

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

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

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Drug Status Breakdown
7 total
  • 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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FDA Approved Drug Record Details Preview

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

Drug Name

OPVEE

Application Number

217470

Product Number

1

Active Ingredient

NALMEFENE HYDROCHLORIDE

Dosage Form

-

Strength

EQ 2.7MG BASE/SPRAY

FDA Approved Drug Data

Approved drug product information

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