Purdue Pharma
FDA Approved Drugs

Purdue Pharma

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
  • Total Records 5
  • Latest Approval Date Nov 23, 2011
  • Data Source FDA
  • First Approval Date Dec 30, 2008
Company Overview

Company

Purdue Pharma

Country

Canada

Website

Visit Website

Email

info@purdue.ca

Social Profiles

Company Snapshot

Purdue Pharma

Purdue Pharma Canada, 575 Granite Court, Pickering, ON Canada L1W 3W8

Canada

purdue.ca/en/ info@purdue.ca View on Map
FDA Approved Drug Records ( 5 records )
2011
23 Nov
Discontinued Application: 22328

Drug Name

INTERMEZZO

Product Number

1

Dosage Form

-

Strength

1.75MG

Approval Date

2011-11-23

22328 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

22328

Product Number

1

Dosage Form

-

Strength

1.75MG

Approval Date

2011-11-23

Regulatory Status

Discontinued

2011
23 Nov
Discontinued Application: 22328

Drug Name

INTERMEZZO

Product Number

2

Dosage Form

-

Strength

3.5MG

Approval Date

2011-11-23

22328 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

22328

Product Number

2

Dosage Form

-

Strength

3.5MG

Approval Date

2011-11-23

Regulatory Status

Discontinued

2008
30 Dec
Discontinued Application: 21745

Drug Name

RYZOLT

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-30

21745 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

21745

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-30

Regulatory Status

Discontinued

2008
30 Dec
Discontinued Application: 21745

Drug Name

RYZOLT

Product Number

2

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-30

21745 / 2

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

21745

Product Number

2

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-30

Regulatory Status

Discontinued

2008
30 Dec
Discontinued Application: 21745

Drug Name

RYZOLT

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-30

21745 / 3

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

21745

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-12-30

Regulatory Status

Discontinued

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Drug Status Breakdown
5 total
  • Discontinued
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

INTERMEZZO

Application Number

22328

Product Number

1

Active Ingredient

ZOLPIDEM TARTRATE

Dosage Form

-

Strength

1.75MG

FDA Approved Drug Data

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