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.
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 Effect | Decreased 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 | Solventum US LLC | 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 | Solventum US LLC | 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: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 2%;70% | ||||
| Approval Date: | Aug 8, 2018 | TE: | 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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