MedPath

Propylene glycol

Generic Name
Propylene glycol
Brand Names
Leader Lubricant Eye Drops, QC ultra lubricant eye, Systane, Systane Balance
Drug Type
Small Molecule
Chemical Formula
C3H8O2
CAS Number
57-55-6
Unique Ingredient Identifier
6DC9Q167V3

Overview

A clear, colorless, viscous organic solvent and diluent used in pharmaceutical preparations.

Indication

No indication information available.

Associated Conditions

  • Dry Eyes
  • Ocular Irritation

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Blenheim Pharmacal, Inc.
10544-874
ORAL
40 mg in 1 1
11/24/2015
American Health Packaging
68084-099
ORAL
40 mg in 1 1
2/3/2023
A-S Medication Solutions
50090-6506
ORAL
80 mg in 1 1
6/14/2023
Proficient Rx LP
71205-188
ORAL
N/A
11/1/2022
NCS HealthCare of KY, LLC dba Vangard Labs
0615-8006
ORAL
10 mg in 1 1
11/10/2023
Cambridge Therapeutics Technologies, LLC
70882-109
ORAL
40 mg in 1 1
6/7/2017
NORTHSTAR RX LLC
16714-174
ORAL
20 mg in 1 1
6/14/2023
A-S Medication Solutions
50090-6480
ORAL
10 mg in 1 1
4/28/2023
NORTHSTAR RX LLC
16714-176
ORAL
80 mg in 1 1
6/14/2023
NuCare Pharmaceuticals,Inc.
68071-2585
ORAL
40 mg in 1 1
7/17/2023

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
SYSTANE ULTRA LUBRICANT EYE DROPS PRESERVATIVE FREE
N/A
alcon hong kong ltd
N/A
N/A
5/21/2012

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
APOTEX-Amlodipine/Atorvastatin 10/10 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 10mg/10mg film-coated tablet blister pack
214402
Medicine
A
7/10/2014
ATORVASTATIN TIH atorvastatin (as calcium propylene glycol solvate) 20 mg film-coated tablet blister pack
384523
Medicine
A
6/10/2022
APOTEX-Amlodipine/Atorvastatin 5/40 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 5 mg/40 mg film-coated tablet blister pack
214396
Medicine
A
7/10/2014
ATORVASTATIN SPR atorvastatin (as calcium propylene glycol solvate) 20 mg film-coated tablet blister pack
384520
Medicine
A
6/10/2022
APOTEX-Amlodipine/Atorvastatin 10/40 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 10mg/40mg film-coated tablet blister pack
214342
Medicine
A
7/10/2014
APOTEX-Amlodipine/Atorvastatin 5/10 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 5mg/10mg film-coated tablet blister pack
214400
Medicine
A
7/10/2014
ATORVASTATIN SPR atorvastatin (as calcium propylene glycol solvate) 10 mg film-coated tablet blister pack
384518
Medicine
A
6/10/2022
ATORVASTATIN SPR atorvastatin (as calcium propylene glycol solvate) 40 mg film-coated tablet blister pack
384521
Medicine
A
6/10/2022
ATORVASTATIN TIH atorvastatin (as calcium propylene glycol solvate) 40 mg film-coated tablet blister pack
384527
Medicine
A
6/10/2022
ATORVASTATIN SPR atorvastatin (as calcium propylene glycol solvate) 80 mg film-coated tablet blister pack
384519
Medicine
A
6/10/2022

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