Sebela Pharmaceuticals
FDA Approved Drugs

Sebela 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.

Discontinued
  • Total Records 6
  • Latest Approval Date Apr 29, 2010
  • Data Source FDA
  • First Approval Date Dec 31, 1985
Company Overview

Company

Sebela Pharmaceuticals

Country

U.S.A

Website

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Company Snapshot

Sebela Pharmaceuticals

645 Hembree Parkway, Suite I Roswell, GA 30076

U.S.A

sebelapharma.com/ View on Map
FDA Approved Drug Records ( 6 records )
2010
29 Apr
Discontinued Application: 22484

Drug Name

ONMEL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2010-04-29

22484 / 1

Active Ingredient

ITRACONAZOLE

Application Number

22484

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2010-04-29

Regulatory Status

Discontinued

2003
03 Jul
Discontinued Application: 21299

Drug Name

PEXEVA

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-07-03

21299 / 1

Active Ingredient

PAROXETINE MESYLATE

Application Number

21299

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2003-07-03

Regulatory Status

Discontinued

2003
03 Jul
Discontinued Application: 21299

Drug Name

PEXEVA

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-07-03

21299 / 2

Active Ingredient

PAROXETINE MESYLATE

Application Number

21299

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-07-03

Regulatory Status

Discontinued

2003
03 Jul
Discontinued Application: 21299

Drug Name

PEXEVA

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2003-07-03

21299 / 3

Active Ingredient

PAROXETINE MESYLATE

Application Number

21299

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2003-07-03

Regulatory Status

Discontinued

2003
03 Jul
Discontinued Application: 21299

Drug Name

PEXEVA

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2003-07-03

21299 / 4

Active Ingredient

PAROXETINE MESYLATE

Application Number

21299

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2003-07-03

Regulatory Status

Discontinued

1985
31 Dec
Discontinued Application: 19425

Drug Name

TRANDATE

Product Number

1

Dosage Form

-

Strength

5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-31

19425 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

19425

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-12-31

Regulatory Status

Discontinued

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Drug Status Breakdown
6 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

ONMEL

Application Number

22484

Product Number

1

Active Ingredient

ITRACONAZOLE

Dosage Form

-

Strength

200MG

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