Guardian Drug Company OTC
FDA Approved Drugs

Guardian Drug Company 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 Mar 15, 2023
  • Data Source FDA
  • First Approval Date Sep 06, 2017
All
15
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Discontinued
1
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OTC
7
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RX
7
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Company Overview

Company

Guardian Drug Company OTC

Country

U.S.A

Social Profiles

Company Snapshot

Guardian Drug Company OTC

2 Charles Court Dayton, NJ 08810 USA

U.S.A

www.guardiandrug.com/ info@guardiandrug.com View on Map
FDA Approved Drug Records ( 7 records )
2023
15 Mar
OTC Application: 216149

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-03-15

216149 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

216149

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-03-15

Regulatory Status

OTC

2017
06 Sep
OTC Application: 209215

Drug Name

GUAIFENESIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2017-09-06

209215 / 1

Active Ingredient

GUAIFENESIN

Application Number

209215

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2017-09-06

Regulatory Status

OTC

2017
06 Sep
OTC Application: 209215

Drug Name

GUAIFENESIN

Product Number

2

Dosage Form

-

Strength

1.2GM

Approval Date

2017-09-06

209215 / 2

Active Ingredient

GUAIFENESIN

Application Number

209215

Product Number

2

Dosage Form

-

Strength

1.2GM

Approval Date

2017-09-06

Regulatory Status

OTC

2018
17 Aug
OTC Application: 210149

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-08-17

210149 / 1

Active Ingredient

IBUPROFEN

Application Number

210149

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-08-17

Regulatory Status

OTC

2018
26 Sep
OTC Application: 210755

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2018-09-26

210755 / 1

Active Ingredient

IBUPROFEN

Application Number

210755

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2018-09-26

Regulatory Status

OTC

2021
27 May
OTC Application: 214541

Drug Name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2021-05-27

214541 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Application Number

214541

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2021-05-27

Regulatory Status

OTC

2019
12 Mar
OTC Application: 207569

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-03-12

207569 / 1

Active Ingredient

LORATADINE

Application Number

207569

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-03-12

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

ESOMEPRAZOLE MAGNESIUM

Application Number

216149

Product Number

1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Dosage Form

-

Strength

EQ 20MG BASE

FDA Approved Drug Data

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