KALEO INC Discontinued
FDA Approved Drugs

KALEO INC Discontinued

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 3
  • Latest Approval Date Feb 28, 2022
  • Data Source FDA
  • First Approval Date Apr 03, 2014
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Discontinued
3
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RX
3
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Company Overview

Company

KALEO INC Discontinued

Country

U.S.A

Website

Social Profiles

Company Snapshot

KALEO INC Discontinued

111 Virginia Street

U.S.A

http://www.kaleopharma.com/contact/ View on Map
FDA Approved Drug Records ( 3 records )
2014
03 Apr
Discontinued Application: 205787

Drug Name

EVZIO

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2014-04-03

205787 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

205787

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2014-04-03

Regulatory Status

Discontinued

2016
19 Oct
Discontinued Application: 209862

Drug Name

EVZIO (AUTOINJECTOR)

Product Number

1

Dosage Form

-

Strength

2MG/0.4ML (2MG/0.4ML)

Approval Date

2016-10-19

209862 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

209862

Product Number

1

Dosage Form

-

Strength

2MG/0.4ML (2MG/0.4ML)

Approval Date

2016-10-19

Regulatory Status

Discontinued

2022
28 Feb
Discontinued Application: 215457

Drug Name

NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Product Number

1

Dosage Form

-

Strength

10MG/0.4ML (10MG/0.4ML)

Approval Date

2022-02-28

215457 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

215457

Product Number

1

Dosage Form

-

Strength

10MG/0.4ML (10MG/0.4ML)

Approval Date

2022-02-28

Regulatory Status

Discontinued

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Drug Status Breakdown
3 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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Explore important FDA approved drug information available in the records above.

Drug Name

EVZIO

Application Number

205787

Product Number

1

Active Ingredient

NALOXONE HYDROCHLORIDE

Dosage Form

-

Strength

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

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