Catalent Pharma Solutions
FDA Approved Drugs

Catalent Pharma Solutions

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 Discontinued RX
  • Total Records 4
  • Latest Approval Date Feb 28, 2025
  • Data Source FDA
  • First Approval Date Oct 29, 1991
All
4
View
Discontinued
1
View
OTC
2
View
RX
1
View
Company Overview

Company

Catalent Pharma Solutions

Country

U.S.A

Social Profiles

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Company Snapshot

Catalent Pharma Solutions

14 Schoolhouse Road, Somerset, NJ 08873

U.S.A

www.catalent.com/ marketing@catalent.com View on Map
FDA Approved Drug Records ( 4 records )
2020
21 Sep
OTC Application: 213105

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-09-21

213105 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

213105

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-09-21

Regulatory Status

OTC

2025
28 Feb
Discontinued Application: 215127

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-02-28

215127 / 1

Active Ingredient

LORATADINE

Application Number

215127

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-02-28

Regulatory Status

Discontinued

2019
04 Jan
OTC Application: 202807

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2019-01-04

202807 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

202807

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2019-01-04

Regulatory Status

OTC

1991
29 Oct
RX Application: 73229

Drug Name

VALPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1991-10-29

73229 / 1

Active Ingredient

VALPROIC ACID

Application Number

73229

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1991-10-29

Regulatory Status

RX

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Drug Status Breakdown
4 total
  • OTC
  • Discontinued
  • RX
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

213105

Product Number

1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

Approved drug product information

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