Novel Laboratories, Inc. OTC
FDA Approved Drugs

Novel Laboratories, Inc. 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 5
  • Latest Approval Date Mar 08, 2016
  • Data Source FDA
  • First Approval Date Oct 06, 2009
All
100
View
Unclassified
4
View
Discontinued
26
View
OTC
5
View
RX
65
View
Company Overview

Company

Novel Laboratories, Inc. OTC

Country

U.S.A

Social Profiles

Company Snapshot

Novel Laboratories, Inc. OTC

400 Campus Drive, Somerset, NJ 08873 

U.S.A

www.novellabs.net/  info@novellabs.net View on Map
FDA Approved Drug Records ( 5 records )
2016
08 Mar
OTC Application: 206793

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-08

206793 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

206793

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-03-08

Regulatory Status

OTC

2016
08 Mar
OTC Application: 206793

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-03-08

206793 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

206793

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-03-08

Regulatory Status

OTC

2013
22 Feb
OTC Application: 202508

Drug Name

LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2013-02-22

202508 / 1

Active Ingredient

LEVONORGESTREL

Application Number

202508

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2013-02-22

Regulatory Status

OTC

2009
06 Oct
OTC Application: 91077

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2009-10-06

91077 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

91077

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2009-10-06

Regulatory Status

OTC

2011
27 Jun
OTC Application: 91077

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2011-06-27

91077 / 2

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

91077

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2011-06-27

Regulatory Status

OTC

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    100 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
5 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

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Application Number

206793

Product Number

1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Dosage Form

-

Strength

5MG

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

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.