Krka
FDA Approved Drugs

Krka

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 Sep 16, 2013
  • Data Source FDA
  • First Approval Date Aug 22, 2000
Company Overview

Company

Krka

Country

Slovenia

Social Profiles

Company Snapshot

Krka

Smarjeska cesta 6, 8501 Novo mesto

Slovenia

www.krka.si/sl/ info@krka.biz View on Map
FDA Approved Drug Records ( 6 records )
2000
22 Aug
Discontinued Application: 75369

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2000-08-22

75369 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

75369

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75369

Drug Name

ENALAPRIL MALEATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2000-08-22

75369 / 2

Active Ingredient

ENALAPRIL MALEATE

Application Number

75369

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75370

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2000-08-22

75370 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

75370

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75370

Drug Name

ENALAPRIL MALEATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-08-22

75370 / 2

Active Ingredient

ENALAPRIL MALEATE

Application Number

75370

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2013
16 Sep
Discontinued Application: 91212

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2013-09-16

91212 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

91212

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2013-09-16

Regulatory Status

Discontinued

2013
16 Sep
Discontinued Application: 91212

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2013-09-16

91212 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

91212

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2013-09-16

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.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ENALAPRIL MALEATE

Application Number

75369

Product Number

1

Active Ingredient

ENALAPRIL MALEATE

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

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