Guardian Drug Company
FDA Approved Drugs

Guardian Drug Company

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 OTC Discontinued
  • Total Records 15
  • Latest Approval Date Nov 21, 2025
  • Data Source FDA
  • First Approval Date Sep 04, 1987
All
15
View
Discontinued
1
View
OTC
7
View
RX
7
View
Company Overview

Company

Guardian Drug Company

Country

U.S.A

Website

Visit Website

Email

info@guardiandrug.com

Social Profiles

Company Snapshot

Guardian Drug Company

2 Charles Court Dayton, NJ 08810 USA

U.S.A

www.guardiandrug.com/ info@guardiandrug.com View on Map
FDA Approved Drug Records ( 15 records )
2022
27 Jun
RX Application: 214201

Drug Name

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

2022-06-27

214201 / 1

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

214201

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

2022-06-27

Regulatory Status

RX

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

1987
04 Sep
Discontinued Application: 71793

Drug Name

FOAMCOAT

Product Number

1

Dosage Form

-

Strength

80MG;20MG

Approval Date

1987-09-04

71793 / 1

Active Ingredient

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

Application Number

71793

Product Number

1

Dosage Form

-

Strength

80MG;20MG

Approval Date

1987-09-04

Regulatory Status

Discontinued

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

2025
21 Nov
RX Application: 218080

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2025-11-21

218080 / 1

Active Ingredient

LEVETIRACETAM

Application Number

218080

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2025-11-21

Regulatory Status

RX

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

2020
30 Apr
RX Application: 212587

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2020-04-30

212587 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

212587

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2020-04-30

Regulatory Status

RX

2020
30 Apr
RX Application: 212587

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM

Approval Date

2020-04-30

212587 / 2

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

212587

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM

Approval Date

2020-04-30

Regulatory Status

RX

2022
30 Dec
RX Application: 214892

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2022-12-30

214892 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

214892

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2022-12-30

Regulatory Status

RX

2022
30 Dec
RX Application: 214892

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2022-12-30

214892 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

214892

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2022-12-30

Regulatory Status

RX

2025
11 Jul
RX Application: 219009

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2025-07-11

219009 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

219009

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2025-07-11

Regulatory Status

RX

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Drug Status Breakdown
15 total
  • RX
  • OTC
  • 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

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

Application Number

214201

Product Number

1

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Dosage Form

-

Strength

66%;10%

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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