Salix Pharmaceuticals
FDA Approved Drugs

Salix Pharmaceuticals

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 30
  • Latest Approval Date Jan 19, 2017
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
30
View
Discontinued
18
View
RX
12
View
Company Overview

Company

Salix Pharmaceuticals

Country

U.S.A

Website

Visit Website

Email

Salixmc@dlss.com

Social Profiles

LinkedIn
Company Snapshot

Salix Pharmaceuticals

400 Somerset Corporate Blvd. Bridgewater, NJ 08807 USA

U.S.A

www.salix.com/ Salixmc@dlss.com View on Map
FDA Approved Drug Records ( 30 records )
1984
06 Jun
RX Application: 88250

Drug Name

ANUSOL HC

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1984-06-06

88250 / 1

Active Ingredient

HYDROCORTISONE

Application Number

88250

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1984-06-06

Regulatory Status

RX

2008
31 Oct
RX Application: 22301

Drug Name

APRISO

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2008-10-31

22301 / 1

Active Ingredient

MESALAMINE

Application Number

22301

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2008-10-31

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 11870

Drug Name

DIURIL

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1982-01-01

11870 / 1

Active Ingredient

CHLOROTHIAZIDE

Application Number

11870

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
10 Aug
Discontinued Application: 22118

Drug Name

FENOGLIDE

Product Number

1

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-08-10

22118 / 1

Active Ingredient

FENOFIBRATE

Application Number

22118

Product Number

1

Dosage Form

-

Strength

40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-08-10

Regulatory Status

Discontinued

2007
10 Aug
Discontinued Application: 22118

Drug Name

FENOGLIDE

Product Number

2

Dosage Form

-

Strength

120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-08-10

22118 / 2

Active Ingredient

FENOFIBRATE

Application Number

22118

Product Number

2

Dosage Form

-

Strength

120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-08-10

Regulatory Status

Discontinued

2005
03 Jun
Discontinued Application: 21748

Drug Name

GLUMETZA

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-06-03

21748 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

21748

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2005-06-03

Regulatory Status

Discontinued

2005
03 Jun
Discontinued Application: 21748

Drug Name

GLUMETZA

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2005-06-03

21748 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

21748

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2005-06-03

Regulatory Status

Discontinued

2009
04 Dec
Discontinued Application: 22456

Drug Name

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

343MG;20MG;750MG

Approval Date

2009-12-04

22456 / 1

Active Ingredient

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Application Number

22456

Product Number

1

Dosage Form

-

Strength

343MG;20MG;750MG

Approval Date

2009-12-04

Regulatory Status

Discontinued

2009
04 Dec
Discontinued Application: 22456

Drug Name

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

343MG;40MG;750MG

Approval Date

2009-12-04

22456 / 2

Active Ingredient

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Application Number

22456

Product Number

2

Dosage Form

-

Strength

343MG;40MG;750MG

Approval Date

2009-12-04

Regulatory Status

Discontinued

2009
04 Sep
Discontinued Application: 22246

Drug Name

METOZOLV ODT

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-09-04

22246 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

22246

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-09-04

Regulatory Status

Discontinued

2009
04 Sep
Discontinued Application: 22246

Drug Name

METOZOLV ODT

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-09-04

22246 / 2

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

22246

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-09-04

Regulatory Status

Discontinued

2006
02 Aug
RX Application: 21881

Drug Name

MOVIPREP

Product Number

1

Dosage Form

-

Strength

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

Approval Date

2006-08-02

21881 / 1

Active Ingredient

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Application Number

21881

Product Number

1

Dosage Form

-

Strength

4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM

Approval Date

2006-08-02

Regulatory Status

RX

2006
16 Mar
Discontinued Application: 21892

Drug Name

OSMOPREP

Product Number

1

Dosage Form

-

Strength

0.398GM;1.102GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-03-16

21892 / 1

Active Ingredient

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Application Number

21892

Product Number

1

Dosage Form

-

Strength

0.398GM;1.102GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-03-16

Regulatory Status

Discontinued

1987
02 Feb
Discontinued Application: 19527

Drug Name

PEPCID

Product Number

1

Dosage Form

-

Strength

40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-02-02

19527 / 1

Active Ingredient

FAMOTIDINE

Application Number

19527

Product Number

1

Dosage Form

-

Strength

40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-02-02

Regulatory Status

Discontinued

2008
24 Apr
RX Application: 21964

Drug Name

RELISTOR

Product Number

1

Dosage Form

-

Strength

12MG/0.6ML (12MG/0.6ML)

Approval Date

2008-04-24

21964 / 1

Active Ingredient

METHYLNALTREXONE BROMIDE

Application Number

21964

Product Number

1

Dosage Form

-

Strength

12MG/0.6ML (12MG/0.6ML)

Approval Date

2008-04-24

Regulatory Status

RX

2010
27 Sep
RX Application: 21964

Drug Name

RELISTOR

Product Number

2

Dosage Form

-

Strength

8MG/0.4ML (8MG/0.4ML)

Approval Date

2010-09-27

21964 / 2

Active Ingredient

METHYLNALTREXONE BROMIDE

Application Number

21964

Product Number

2

Dosage Form

-

Strength

8MG/0.4ML (8MG/0.4ML)

Approval Date

2010-09-27

Regulatory Status

RX

2010
27 Sep
RX Application: 21964

Drug Name

RELISTOR

Product Number

3

Dosage Form

-

Strength

12MG/0.6ML (12MG/0.6ML)

Approval Date

2010-09-27

21964 / 3

Active Ingredient

METHYLNALTREXONE BROMIDE

Application Number

21964

Product Number

3

Dosage Form

-

Strength

12MG/0.6ML (12MG/0.6ML)

Approval Date

2010-09-27

Regulatory Status

RX

2016
19 Jul
RX Application: 208271

Drug Name

RELISTOR

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-07-19

208271 / 1

Active Ingredient

METHYLNALTREXONE BROMIDE

Application Number

208271

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-07-19

Regulatory Status

RX

2017
19 Jan
RX Application: 208745

Drug Name

TRULANCE

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2017-01-19

208745 / 1

Active Ingredient

PLECANATIDE

Application Number

208745

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2017-01-19

Regulatory Status

RX

2013
14 Jan
RX Application: 203634

Drug Name

UCERIS

Product Number

1

Dosage Form

-

Strength

9MG

Approval Date

2013-01-14

203634 / 1

Active Ingredient

BUDESONIDE

Application Number

203634

Product Number

1

Dosage Form

-

Strength

9MG

Approval Date

2013-01-14

Regulatory Status

RX

2014
07 Oct
RX Application: 205613

Drug Name

UCERIS

Product Number

1

Dosage Form

-

Strength

2MG/ACTUATION

Approval Date

2014-10-07

205613 / 1

Active Ingredient

BUDESONIDE

Application Number

205613

Product Number

1

Dosage Form

-

Strength

2MG/ACTUATION

Approval Date

2014-10-07

Regulatory Status

RX

2000
21 Sep
Discontinued Application: 21097

Drug Name

VISICOL

Product Number

1

Dosage Form

-

Strength

0.398GM;1.102GM

Approval Date

2000-09-21

21097 / 1

Active Ingredient

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Application Number

21097

Product Number

1

Dosage Form

-

Strength

0.398GM;1.102GM

Approval Date

2000-09-21

Regulatory Status

Discontinued

2004
25 May
RX Application: 21361

Drug Name

XIFAXAN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2004-05-25

21361 / 1

Active Ingredient

RIFAXIMIN

Application Number

21361

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2004-05-25

Regulatory Status

RX

2010
24 Mar
RX Application: 21361

Drug Name

XIFAXAN

Product Number

2

Dosage Form

-

Strength

550MG

Approval Date

2010-03-24

21361 / 2

Active Ingredient

RIFAXIMIN

Application Number

21361

Product Number

2

Dosage Form

-

Strength

550MG

Approval Date

2010-03-24

Regulatory Status

RX

2004
15 Jun
Discontinued Application: 21636

Drug Name

ZEGERID

Product Number

1

Dosage Form

-

Strength

20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-06-15

21636 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

21636

Product Number

1

Dosage Form

-

Strength

20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-06-15

Regulatory Status

Discontinued

2004
21 Dec
Discontinued Application: 21636

Drug Name

ZEGERID

Product Number

2

Dosage Form

-

Strength

40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-21

21636 / 2

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

21636

Product Number

2

Dosage Form

-

Strength

40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-21

Regulatory Status

Discontinued

2006
27 Feb
Discontinued Application: 21849

Drug Name

ZEGERID

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-02-27

21849 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

21849

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-02-27

Regulatory Status

Discontinued

2006
27 Feb
Discontinued Application: 21849

Drug Name

ZEGERID

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-02-27

21849 / 2

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

21849

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-02-27

Regulatory Status

Discontinued

2006
24 Mar
Discontinued Application: 21850

Drug Name

ZEGERID

Product Number

1

Dosage Form

-

Strength

700MG;20MG;600MG

Approval Date

2006-03-24

21850 / 1

Active Ingredient

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Application Number

21850

Product Number

1

Dosage Form

-

Strength

700MG;20MG;600MG

Approval Date

2006-03-24

Regulatory Status

Discontinued

2006
24 Mar
Discontinued Application: 21850

Drug Name

ZEGERID

Product Number

2

Dosage Form

-

Strength

700MG;40MG;600MG

Approval Date

2006-03-24

21850 / 2

Active Ingredient

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Application Number

21850

Product Number

2

Dosage Form

-

Strength

700MG;40MG;600MG

Approval Date

2006-03-24

Regulatory Status

Discontinued

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Drug Status Breakdown
30 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

ANUSOL HC

Application Number

88250

Product Number

1

Active Ingredient

HYDROCORTISONE

Dosage Form

-

Strength

2.5%

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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