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esomeprazole magnesium dihydrate

Generic Name
esomeprazole magnesium dihydrate

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
NuCare Pharmaceuticals,Inc.
68071-5117
ORAL
40 mg in 1 1
2/22/2021
Teva Pharmaceuticals USA, Inc.
0093-6450
ORAL
20 mg in 1 1
12/30/2022
Zydus Lifesciences Limited
70771-1391
ORAL
20 mg in 1 1
6/19/2023
Zydus Pharmaceuticals USA Inc.
68382-849
ORAL
40 mg in 1 1
8/17/2023
Bryant Ranch Prepack
71335-0807
ORAL
20 mg in 1 1
3/23/2022
Advanced Rx Pharmacy of Tennessee, LLC
80425-0111
ORAL
20 mg in 1 1
11/17/2022
Bryant Ranch Prepack
71335-1335
ORAL
40 mg in 1 1
3/30/2022
medsourcer pharmaceuticals
45865-892
ORAL
20 mg in 1 1
12/26/2018
Zydus Pharmaceuticals USA Inc.
68382-848
ORAL
20 mg in 1 1
8/17/2023
Zydus Pharmaceuticals USA Inc.
68382-442
ORAL
40 mg in 1 1
10/5/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
ESOMEPRAZOLE SANDOZ Hp7 amoxicillin (as trihydrate) 500mg capsule, clarithromycin 500 mg tablet, esomeprazole (as magnesium trihydrate) 20 mg tablet Composite Pack
408831
Medicine
A
8/17/2023
ESOMEPRAZOLE APOTEX esomeprazole magnesium dihydrate 40mg enteric coated tablet blister pack
210843
Medicine
A
7/30/2014
ESOMEPRAZOLE SPIRIT esomeprazole magnesium dihydrate 40mg enteric coated tablet blister pack
210847
Medicine
A
7/30/2014
MEPREZE 24HR ONCE DAILY DOSING esomeprazole 20 mg (as magnesium dihydrate) enteric coated tablet blister pack
300206
Medicine
A
3/1/2018
APOHEALTH ESOMEPRAZOLE HEARTBURN RELIEF esomeprazole (as magnesium dihydrate) 20 mg enteric coated tablet blister pack
300205
Medicine
A
3/1/2018
ESOMEPRAZOLE SANDOZ esomeprazole (as magnesium dihydrate) 20 mg enteric coated tablet blister pack
210841
Medicine
A
7/30/2014
ESOMEPRAZOLE VIATRIS esomeprazole (as magnesium dihydrate) 20 mg enteric coated tablet blister pack
210854
Medicine
A
7/30/2014
ESOMEPRAZOLE VIATRIS esomeprazole (as magnesium dihydrate) 40 mg enteric coated tablet blister pack
210844
Medicine
A
7/30/2014
ESOMEPRAZOLE APOTEX esomeprazole magnesium dihydrate 20mg enteric coated tablet blister pack
210849
Medicine
A
7/30/2014
PHARMACY CHOICE ESOMEPRAZOLE HEARTBURN RELIEF esomeprazole (as magnesium dihydrate) 20 mg enteric capsule blister pack
301679
Medicine
A
4/9/2018

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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