BioDelivery Sciences
FDA Approved Drugs

BioDelivery Sciences

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 Discontinued
  • Total Records 11
  • Latest Approval Date Mar 23, 2017
  • Data Source FDA
  • First Approval Date Jun 06, 2014
All
11
View
Discontinued
3
View
RX
8
View
Company Overview

Company

BioDelivery Sciences

Country

U.S.A

Website

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Company Snapshot

BioDelivery Sciences

4131 ParkLake Avenue, Suite 225 Raleigh, NC 27612

U.S.A

bdsi.com/ View on Map
FDA Approved Drug Records ( 11 records )
2015
23 Oct
RX Application: 207932

Drug Name

BELBUCA

Product Number

1

Dosage Form

-

Strength

EQ 0.075MG BASE

Approval Date

2015-10-23

207932 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207932

Product Number

1

Dosage Form

-

Strength

EQ 0.075MG BASE

Approval Date

2015-10-23

Regulatory Status

RX

2015
23 Oct
RX Application: 207932

Drug Name

BELBUCA

Product Number

2

Dosage Form

-

Strength

EQ 0.15MG BASE

Approval Date

2015-10-23

207932 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207932

Product Number

2

Dosage Form

-

Strength

EQ 0.15MG BASE

Approval Date

2015-10-23

Regulatory Status

RX

2015
23 Oct
RX Application: 207932

Drug Name

BELBUCA

Product Number

3

Dosage Form

-

Strength

EQ 0.3MG BASE

Approval Date

2015-10-23

207932 / 3

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207932

Product Number

3

Dosage Form

-

Strength

EQ 0.3MG BASE

Approval Date

2015-10-23

Regulatory Status

RX

2015
23 Oct
RX Application: 207932

Drug Name

BELBUCA

Product Number

4

Dosage Form

-

Strength

EQ 0.45MG BASE

Approval Date

2015-10-23

207932 / 4

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207932

Product Number

4

Dosage Form

-

Strength

EQ 0.45MG BASE

Approval Date

2015-10-23

Regulatory Status

RX

2015
23 Oct
RX Application: 207932

Drug Name

BELBUCA

Product Number

5

Dosage Form

-

Strength

EQ 0.6MG BASE

Approval Date

2015-10-23

207932 / 5

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207932

Product Number

5

Dosage Form

-

Strength

EQ 0.6MG BASE

Approval Date

2015-10-23

Regulatory Status

RX

2015
23 Oct
RX Application: 207932

Drug Name

BELBUCA

Product Number

6

Dosage Form

-

Strength

EQ 0.75MG BASE

Approval Date

2015-10-23

207932 / 6

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207932

Product Number

6

Dosage Form

-

Strength

EQ 0.75MG BASE

Approval Date

2015-10-23

Regulatory Status

RX

2015
23 Oct
RX Application: 207932

Drug Name

BELBUCA

Product Number

7

Dosage Form

-

Strength

EQ 0.9MG BASE

Approval Date

2015-10-23

207932 / 7

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207932

Product Number

7

Dosage Form

-

Strength

EQ 0.9MG BASE

Approval Date

2015-10-23

Regulatory Status

RX

2014
06 Jun
Discontinued Application: 205637

Drug Name

BUNAVAIL

Product Number

1

Dosage Form

-

Strength

EQ 2.1MG BASE;EQ 0.3MG BASE

Approval Date

2014-06-06

205637 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205637

Product Number

1

Dosage Form

-

Strength

EQ 2.1MG BASE;EQ 0.3MG BASE

Approval Date

2014-06-06

Regulatory Status

Discontinued

2014
06 Jun
Discontinued Application: 205637

Drug Name

BUNAVAIL

Product Number

2

Dosage Form

-

Strength

EQ 4.2MG BASE;EQ 0.7MG BASE

Approval Date

2014-06-06

205637 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205637

Product Number

2

Dosage Form

-

Strength

EQ 4.2MG BASE;EQ 0.7MG BASE

Approval Date

2014-06-06

Regulatory Status

Discontinued

2014
06 Jun
Discontinued Application: 205637

Drug Name

BUNAVAIL

Product Number

3

Dosage Form

-

Strength

EQ 6.3MG BASE;EQ 1MG BASE

Approval Date

2014-06-06

205637 / 3

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205637

Product Number

3

Dosage Form

-

Strength

EQ 6.3MG BASE;EQ 1MG BASE

Approval Date

2014-06-06

Regulatory Status

Discontinued

2017
23 Mar
RX Application: 208854

Drug Name

SYMPROIC

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE

Approval Date

2017-03-23

208854 / 1

Active Ingredient

NALDEMEDINE TOSYLATE

Application Number

208854

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE

Approval Date

2017-03-23

Regulatory Status

RX

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Drug Status Breakdown
11 total
  • RX
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

BELBUCA

Application Number

207932

Product Number

1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Dosage Form

-

Strength

EQ 0.075MG BASE

FDA Approved Drug Data

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