Details for New Drug Application (NDA): 021586
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NDA 021586 describes DURAPREP, which is a drug marketed by 3M and is included in one NDA. It is available from one supplier. Additional details are available on the DURAPREP profile page.
The generic ingredient in DURAPREP is iodine povacrylex; isopropyl alcohol. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iodine povacrylex; isopropyl alcohol profile page.
The generic ingredient in DURAPREP is iodine povacrylex; isopropyl alcohol. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iodine povacrylex; isopropyl alcohol profile page.
Summary for 021586
| Tradename: | DURAPREP |
| Applicant: | 3m |
| Ingredient: | iodine povacrylex; isopropyl alcohol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021586
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DURAPREP | iodine povacrylex; isopropyl alcohol | SPONGE;TOPICAL | 021586 | NDA | Solventum US LLC | 17518-011 | 17518-011-07 | 1 APPLICATOR in 1 CASE (17518-011-07) / 6 mL in 1 APPLICATOR |
| DURAPREP | iodine povacrylex; isopropyl alcohol | SPONGE;TOPICAL | 021586 | NDA | Solventum US LLC | 17518-011 | 17518-011-08 | 1 APPLICATOR in 1 CASE (17518-011-08) / 26 mL in 1 APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPONGE;TOPICAL | Strength | EQ 0.7% IODINE;74% (6ML) | ||||
| Approval Date: | Sep 29, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPONGE;TOPICAL | Strength | EQ 0.7% IODINE;74% (26ML) | ||||
| Approval Date: | Sep 29, 2006 | TE: | RLD: | Yes | |||||
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