AstraZeneca OTC
FDA Approved Drugs

AstraZeneca OTC

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.

OTC
  • Total Records 3
  • Latest Approval Date Nov 23, 2015
  • Data Source FDA
  • First Approval Date Jun 20, 2003
All
185
View
Unclassified
15
View
Discontinued
114
View
OTC
3
View
RX
53
View
Company Overview

Company

AstraZeneca OTC

Country

United Kingdom

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Company Snapshot

AstraZeneca OTC

2 Kingdom Street, Paddington, London W2 6BD

United Kingdom

www.astrazeneca.com/ Russell.Gantt@astrazeneca.com View on Map
FDA Approved Drug Records ( 3 records )
2014
28 Mar
OTC Application: 204655

Drug Name

NEXIUM 24HR

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-03-28

204655 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

204655

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-03-28

Regulatory Status

OTC

2015
23 Nov
OTC Application: 207920

Drug Name

NEXIUM 24HR

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-11-23

207920 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

207920

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2015-11-23

Regulatory Status

OTC

2003
20 Jun
OTC Application: 21229

Drug Name

PRILOSEC OTC

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-06-20

21229 / 1

Active Ingredient

OMEPRAZOLE MAGNESIUM

Application Number

21229

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2003-06-20

Regulatory Status

OTC

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Drug Status Breakdown
3 total
  • OTC
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

NEXIUM 24HR

Application Number

204655

Product Number

1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Dosage Form

-

Strength

EQ 20MG BASE

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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