Esteve Quimica
FDA Approved Drugs

Esteve Quimica

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 8
  • Latest Approval Date Oct 04, 2019
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
8
View
Discontinued
2
View
RX
6
View
Company Overview

Company

Esteve Quimica

Country

Spain

Website

Visit Website

Email

eqcomercial@eqesteve.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Esteve Quimica

Passeig de la Zona Franca, 109, 4º Planta, 08038 Barcelona

Spain

www.estevequimica.com/ eqcomercial@eqesteve.com View on Map
FDA Approved Drug Records ( 8 records )
1982
01 Jan
RX Application: 16885

Drug Name

LYSODREN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

16885 / 1

Active Ingredient

MITOTANE

Application Number

16885

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 12911

Drug Name

METOPIRONE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

12911 / 1

Active Ingredient

METYRAPONE

Application Number

12911

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
09 Aug
RX Application: 12911

Drug Name

METOPIRONE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1996-08-09

12911 / 2

Active Ingredient

METYRAPONE

Application Number

12911

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1996-08-09

Regulatory Status

RX

2004
28 Dec
RX Application: 21060

Drug Name

PRIALT

Product Number

1

Dosage Form

-

Strength

500MCG/20ML (25MCG/ML)

Approval Date

2004-12-28

21060 / 1

Active Ingredient

ZICONOTIDE ACETATE

Application Number

21060

Product Number

1

Dosage Form

-

Strength

500MCG/20ML (25MCG/ML)

Approval Date

2004-12-28

Regulatory Status

RX

2004
28 Dec
RX Application: 21060

Drug Name

PRIALT

Product Number

2

Dosage Form

-

Strength

100MCG/1ML (100MCG/ML)

Approval Date

2004-12-28

21060 / 2

Active Ingredient

ZICONOTIDE ACETATE

Application Number

21060

Product Number

2

Dosage Form

-

Strength

100MCG/1ML (100MCG/ML)

Approval Date

2004-12-28

Regulatory Status

RX

2004
28 Dec
Discontinued Application: 21060

Drug Name

PRIALT

Product Number

3

Dosage Form

-

Strength

200MCG/2ML (100MCG/ML)

Approval Date

2004-12-28

21060 / 3

Active Ingredient

ZICONOTIDE ACETATE

Application Number

21060

Product Number

3

Dosage Form

-

Strength

200MCG/2ML (100MCG/ML)

Approval Date

2004-12-28

Regulatory Status

Discontinued

2004
28 Dec
RX Application: 21060

Drug Name

PRIALT

Product Number

4

Dosage Form

-

Strength

500MCG/5ML (100MCG/ML)

Approval Date

2004-12-28

21060 / 4

Active Ingredient

ZICONOTIDE ACETATE

Application Number

21060

Product Number

4

Dosage Form

-

Strength

500MCG/5ML (100MCG/ML)

Approval Date

2004-12-28

Regulatory Status

RX

2019
04 Oct
RX Application: 211415

Drug Name

QUZYTTIR

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2019-10-04

211415 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

211415

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2019-10-04

Regulatory Status

RX

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Drug Status Breakdown
8 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

LYSODREN

Application Number

16885

Product Number

1

Active Ingredient

MITOTANE

Dosage Form

-

Strength

500MG

FDA Approved Drug Data

Approved drug product information

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