MedPath

Naloxone Hydrochloride/Pentazocine Hydrochloride

Generic Name
Naloxone Hydrochloride/Pentazocine 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
American Health Packaging
60687-637
SUBLINGUAL
2 mg in 1 1
5/9/2023
SpecGx LLC
0406-8005
SUBLINGUAL
0.5 mg in 1 1
1/3/2024
Rhodes Pharmaceuticals L.P.
42858-601
SUBLINGUAL
0.5 mg in 1 1
12/28/2023
Mylan Pharmaceuticals Inc.
0378-8767
SUBLINGUAL, BUCCAL
2 mg in 1 1
3/31/2021
Mylan Pharmaceuticals Inc.
0378-8765
SUBLINGUAL, BUCCAL
0.5 mg in 1 1
3/31/2021
Alvogen Inc.
47781-355
SUBLINGUAL, BUCCAL
0.5 mg in 1 1
3/30/2018
Sun Pharmaceutical Industries, Inc.
62756-969
SUBLINGUAL
0.5 mg in 1 1
11/6/2023
Accord Healthcare, Inc
16729-549
SUBLINGUAL
0.5 mg in 1 1
5/3/2023
Bryant Ranch Prepack
72162-1347
SUBLINGUAL
2 mg in 1 1
3/12/2024
Bryant Ranch Prepack
71335-1296
SUBLINGUAL
0.5 mg in 1 1
7/20/2022

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
APO OXYCODONE NALOXONE XR 20/10 oxycodone hydrochloride 20mg naloxone hydrochloride 10mg modified release tablet blister
330688
Medicine
A
7/3/2024
SUBOXONE FILM 2/0.5 buprenorphine (as hydrochloride) 2 mg/naloxone (as hydrochloride dihydrate) 0.5 mg soluble film sachet
163443
Medicine
A
2/18/2011
TARGIN oxycodone hydrochloride / naloxone hydrochloride 20/10 mg modified release tablets blister pack
156189
Medicine
A
5/12/2010
NALOXONE JUNO NEONATAL naloxone hydrochloride (as dihydrate) 40 micrograms/2 mL solution for injection, ampoule
236003
Medicine
A
3/10/2016
OXYN NALOXONE XR 10/5 oxycodone hydrochloride 10mg naloxone hydrochloride 5mg modified release tablet blister
330682
Medicine
A
7/3/2024
TARGIN oxycodone hydrochloride / naloxone hydrochloride anhydrous 80/40 mg modified release tablets blister pack
243272
Medicine
A
7/20/2016
Oxonal 10/5 oxycodone hydrochloride/naloxone hydrochloride 10 mg/5 mg modified release tablet blister
414724
AU Pharma Pty Ltd
Medicine
A
4/9/2024
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 60/30 mg modified release tablet blister pack
288271
Medicine
A
10/17/2022
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 30/15mg modified release tablet blister pack
288269
Medicine
A
10/17/2022
MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 40/20 mg modified release tablet blister pack
288270
Medicine
A
10/17/2022

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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.