Application 021074
- Type
- NDA
- Sponsor
- 3M
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVAGARD | ALCOHOL; CHLORHEXIDINE GLUCONATE | SOLUTION;TOPICAL | 61%;1% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17518-051 | 3M Avagard | Chlorhexidine Gluconate and Alcohol | 3M Health Care | NDA | Current |
| 17518-051 | 3M Avagard | Chlorhexidine Gluconate and Alcohol | 3M Company | NDA | Current |
| 17518-051 | 3M Avagard | Chlorhexidine Gluconate and Alcohol | 3M Company | NDA | Current |
| 17518-051 | 3M Avagard | Chlorhexidine Gluconate and Alcohol | 3M Company | NDA | Current |
| 17518-051 | 3M Avagard | Chlorhexidine Gluconate and Alcohol | 3M Health Care | NDA | Current |
| 17518-051 | 3M Avagard | Chlorhexidine Gluconate and Alcohol | 3M Health Care | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49704 | SUPPL | 2017-09-08 |
| 49697 | SUPPL | 2017-09-08 |
| 45899 | SUPPL | 2016-11-16 |
| 45838 | SUPPL | 2016-11-08 |
| 26647 | SUPPL | 2015-11-16 |
| 36022 | SUPPL | 2015-11-13 |
| 36021 | SUPPL | 2014-01-14 |
| 4221 | SUPPL | 2013-02-20 |
| 4220 | SUPPL | 2012-06-11 |
| 4219 | SUPPL | 2012-05-21 |
| 21417 | ORIG | 2004-05-27 |
| 14293 | ORIG | 2001-10-02 |
| 4218 | ORIG | 2001-10-02 |