Viatris OTC
FDA Approved Drugs

Viatris 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 7
  • Latest Approval Date Oct 06, 2009
  • Data Source FDA
  • First Approval Date Aug 20, 2003
All
922
View
Unclassified
87
View
Discontinued
317
View
OTC
7
View
RX
511
View
Company Overview

Company

Viatris OTC

Country

U.S.A

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Viatris OTC

Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317

U.S.A

www.viatris.com/en HRServiceCenter@Viatris.com View on Map
FDA Approved Drug Records ( 7 records )
2007
27 Dec
OTC Application: 76677

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

76677 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

76677

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

Regulatory Status

OTC

2007
27 Dec
OTC Application: 76677

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

76677 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

76677

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

Regulatory Status

OTC

2007
27 Dec
OTC Application: 76677

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

76677 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

76677

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

Regulatory Status

OTC

2007
27 Dec
OTC Application: 76677

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

76677 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

76677

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

Regulatory Status

OTC

2003
20 Aug
OTC Application: 76154

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-08-20

76154 / 1

Active Ingredient

LORATADINE

Application Number

76154

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-08-20

Regulatory Status

OTC

2009
06 Oct
OTC Application: 78915

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

1

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2009-10-06

78915 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

78915

Product Number

1

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2009-10-06

Regulatory Status

OTC

2009
06 Oct
OTC Application: 78915

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

2

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2009-10-06

78915 / 2

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

78915

Product Number

2

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2009-10-06

Regulatory Status

OTC

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Drug Status Breakdown
7 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

CETIRIZINE HYDROCHLORIDE ALLERGY

Application Number

76677

Product Number

1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Dosage Form

-

Strength

5MG

FDA Approved Drug Data

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