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paroxetine hydrochloride hemihydrate

Generic Name
paroxetine hydrochloride hemihydrate

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
Sinotherapeutics Inc.
69986-011
ORAL
12.5 mg in 1 1
10/31/2022
Solco Healthcare US, LLC
43547-350
ORAL
40 mg in 1 1
10/25/2018
Apotex Corp.
60505-0097
ORAL
10 mg in 1 1
9/26/2023
REMEDYREPACK INC.
70518-2574
ORAL
10 mg in 1 1
1/22/2024
Modavar Pharmaceuticals LLC
72241-030
ORAL
25 mg in 1 1
12/19/2023
Aurobindo Pharma Limited
65862-156
ORAL
30 mg in 1 1
9/8/2023
American Health Packaging
68084-046
ORAL
30 mg in 1 1
10/4/2022
Chartwell RX, LLC.
62135-543
ORAL
30 mg in 1 1
4/18/2023
ANI Pharmaceuticals, Inc.
70954-319
ORAL
10 mg in 5 mL
10/17/2023
Bryant Ranch Prepack
63629-9500
ORAL
37.5 mg in 1 1
3/4/2021

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
SEROXAT CR CONTROLLED-RELEASE TAB 25MG
N/A
N/A
N/A
3/2/2004
SEROXAT CR CONTROLLED-RELEASE TAB 12.5MG
N/A
N/A
N/A
3/2/2004
SEROXAT TABLETS 20MG
N/A
N/A
N/A
9/22/2016

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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