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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 208288


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NDA 208288 describes SOLUPREP S, which is a drug marketed by 3m Health Care and is included in one NDA. It is available from one supplier. Additional details are available on the SOLUPREP S profile page.

The generic ingredient in SOLUPREP S is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.
Summary for 208288
Tradename:SOLUPREP S
Applicant:3m Health Care
Ingredient:chlorhexidine gluconate; isopropyl alcohol
Patents:0
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208288
Generic Entry Date for 208288*:
Constraining patent/regulatory exclusivity:
REVISIONS TO THE LABELING TO DESCRIBE MODIFIED FORMULATION BASED ON RESULTS OF STUDIES EM-05-014624 AND EM-05-014815
Dosage:
SOLUTION;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 208288
Physiological EffectDecreased Cell Wall Integrity
Suppliers and Packaging for NDA: 208288
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUPREP S chlorhexidine gluconate; isopropyl alcohol SOLUTION;TOPICAL 208288 NDA 3M Company 17518-082 17518-082-01 1 APPLICATOR in 1 POUCH (17518-082-01) / 26 mL in 1 APPLICATOR
SOLUPREP S chlorhexidine gluconate; isopropyl alcohol SOLUTION;TOPICAL 208288 NDA 3M Company 17518-082 17518-082-02 1 APPLICATOR in 1 POUCH (17518-082-02) / 10.5 mL in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength2%;70%
Approval Date:Aug 8, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 20, 2026
Regulatory Exclusivity Use:REVISIONS TO THE LABELING TO DESCRIBE MODIFIED FORMULATION BASED ON RESULTS OF STUDIES EM-05-014624 AND EM-05-014815

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