MedPath

Dicyclomine Hydrochloride

Generic Name
Dicyclomine Hydrochloride

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
Actavis Pharma, Inc.
0591-0795
ORAL
20 mg in 1 1
11/30/2020
A-S Medication Solutions
50090-0127
ORAL
10 mg in 1 1
9/17/2018
RedPharm Drug, Inc.
67296-1409
ORAL
10 mg in 1 1
1/1/2021
Golden State Medical Supply, Inc.
51407-783
ORAL
10 mg in 1 1
7/24/2023
RedPharm Drug, Inc.
67296-1039
ORAL
20 mg in 1 1
3/9/2023
RPK Pharmaceuticals, Inc.
53002-3450
ORAL
20 mg in 1 1
11/28/2018
Preferred Pharmaceuticals, Inc.
68788-9525
ORAL
20 mg in 1 1
5/5/2023
Preferred Pharmaceuticals Inc.
68788-8581
ORAL
20 mg in 1 1
2/6/2024
PD-Rx Pharmaceuticals, Inc.
43063-045
ORAL
20 mg in 1 1
5/10/2023
Lake Erie Medical DBA Quality Care Products LLC
49999-081
ORAL
20 mg in 1 1
1/27/2017

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PROTYLOL
PRO DOC LIMITEE
00287709
Capsule - Oral
10 MG
12/31/1974
RIVA-DICYCLOMINE
laboratoire riva inc.
00557102
Capsule - Oral
10 MG
12/31/1982
BENTYLOL DOSPAN 30MG
merrell pharms inc., division of merrell dow (can)
00218723
Tablet (Extended-Release) - Oral
30 MG / TAB
3/23/1988
DICYCLOMINE CAP 10MG
00431028
Capsule - Oral
10 MG / CAP
12/31/1978
SPASMO NIL TAB
00430897
Tablet - Oral
2.5 MG
12/31/1978
DICYCLOMINE HYDROCHLORIDE INJECTION USP
00392812
Solution - Intramuscular
10 MG / ML
12/31/1976
DICYCLOMINE HYDROCHLORIDE USP
00392820
Capsule - Oral
10 MG
12/31/1976
BENTYLOL
Aptalis Pharma Canada ULC
02102978
Syrup - Oral
10 MG / 5 ML
12/31/1993
BENTYLOL TABLET 10MG
Aptalis Pharma Canada ULC
02103087
Tablet - Oral
10 MG
12/31/1995
BENTYLOL TABLET 20MG
Aptalis Pharma Canada ULC
02103095
Tablet - Oral
20 MG
12/31/1995

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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