Bayer AG OTC
FDA Approved Drugs

Bayer AG 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 4
  • Latest Approval Date Jun 17, 2021
  • Data Source FDA
  • First Approval Date Jan 11, 1994
All
277
View
Unclassified
23
View
Discontinued
190
View
OTC
4
View
RX
60
View
Company Overview

Company

Bayer AG OTC

Country

Germany

Social Profiles

Company Snapshot

Bayer AG OTC

Mullerstr. 178, 13353 Berlin

Germany

pharma.bayer.com/ pharmachemicals@bayer.com View on Map
FDA Approved Drug Records ( 4 records )
1994
11 Jan
OTC Application: 20204

Drug Name

ALEVE

Product Number

2

Dosage Form

-

Strength

220MG

Approval Date

1994-01-11

20204 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

20204

Product Number

2

Dosage Form

-

Strength

220MG

Approval Date

1994-01-11

Regulatory Status

OTC

2014
17 Jan
OTC Application: 205352

Drug Name

ALEVE PM

Product Number

1

Dosage Form

-

Strength

25MG;220MG

Approval Date

2014-01-17

205352 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Application Number

205352

Product Number

1

Dosage Form

-

Strength

25MG;220MG

Approval Date

2014-01-17

Regulatory Status

OTC

2021
17 Jun
OTC Application: 213872

Drug Name

ASTEPRO ALLERGY

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2021-06-17

213872 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

213872

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2021-06-17

Regulatory Status

OTC

2021
17 Jun
OTC Application: 213872

Drug Name

CHILDRENS ASTEPRO ALLERGY

Product Number

2

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2021-06-17

213872 / 2

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

213872

Product Number

2

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2021-06-17

Regulatory Status

OTC

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Drug Status Breakdown
4 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

ALEVE

Application Number

20204

Product Number

2

Active Ingredient

NAPROXEN SODIUM

Dosage Form

-

Strength

220MG

FDA Approved Drug Data

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