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FDA Approval

GoodSense Eye Drops Advanced Relief Moisturizer

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 7, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Tetryzoline(0.05 g in 100 mL)
Povidone(1 g in 100 mL)
Dextran(0.1 g in 100 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Preferred PHarmaceuticals Inc.

791119022

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Preferred PHarmaceuticals Inc.

Preferred PHarmaceuticals Inc.

Preferred PHarmaceuticals Inc.

791119022

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

GoodSense Eye Drops Advanced Relief Moisturizer

Product Details

NDC Product Code
68788-8635
Application Number
M018
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
OPHTHALMIC
Effective Date
May 7, 2025
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QOClass: IACT
Code: B697894SGQClass: ACTIBQuantity: 1 g in 100 mL
Code: 0YZT43HS7DClass: ACTIBQuantity: 0.05 g in 100 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
PovidoneActive
Code: FZ989GH94EClass: ACTIBQuantity: 1 g in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
DextranActive
Code: 7SA290YK68Class: ACTIBQuantity: 0.1 g in 100 mL
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