Apotex Fermentation Inc. OTC
FDA Approved Drugs

Apotex Fermentation 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 8
  • Latest Approval Date May 29, 2024
  • Data Source FDA
  • First Approval Date Feb 14, 2006
All
558
View
Unclassified
9
View
Discontinued
263
View
OTC
8
View
RX
278
View
Company Overview

Company

Apotex Fermentation Inc. OTC

Country

Canada

Website

Visit Website

Email

services@apoferm.com

Social Profiles

Company Snapshot

Apotex Fermentation Inc. OTC

50 Scurfield BoulevardWinnipeg, ManitobaCanada R3Y 1G4

Canada

www.apoferm.com/ services@apoferm.com View on Map
FDA Approved Drug Records ( 8 records )
2024
29 May
OTC Application: 216421

Drug Name

AZELASTINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2024-05-29

216421 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

216421

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2024-05-29

Regulatory Status

OTC

2024
29 May
OTC Application: 216421

Drug Name

AZELASTINE HYDROCHLORIDE CHILDRENS ALLERGY

Product Number

2

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2024-05-29

216421 / 2

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

216421

Product Number

2

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2024-05-29

Regulatory Status

OTC

2015
20 Nov
OTC Application: 78949

Drug Name

BUDESONIDE

Product Number

2

Dosage Form

-

Strength

0.032MG/SPRAY

Approval Date

2015-11-20

78949 / 2

Active Ingredient

BUDESONIDE

Application Number

78949

Product Number

2

Dosage Form

-

Strength

0.032MG/SPRAY

Approval Date

2015-11-20

Regulatory Status

OTC

2016
29 Feb
OTC Application: 208150

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2016-02-29

208150 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208150

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2016-02-29

Regulatory Status

OTC

2006
14 Feb
OTC Application: 76471

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-02-14

76471 / 1

Active Ingredient

LORATADINE

Application Number

76471

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-02-14

Regulatory Status

OTC

2015
07 Dec
OTC Application: 78350

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2015-12-07

78350 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

78350

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2015-12-07

Regulatory Status

OTC

2017
05 Dec
OTC Application: 90918

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2017-12-05

90918 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

90918

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2017-12-05

Regulatory Status

OTC

2023
19 Jan
OTC Application: 214615

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2023-01-19

214615 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

214615

Product Number

1

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2023-01-19

Regulatory Status

OTC

Related Databases
  • FDA Inspections
    4 View
  • EDQM CEP
    1 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    558 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
8 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

AZELASTINE HYDROCHLORIDE ALLERGY

Application Number

216421

Product Number

1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Dosage Form

-

Strength

0.2055MG/SPRAY

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.
Login to Submit