Application 207964
- Type
- NDA
- Sponsor
- MEDLINE INDUSTRIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | READYPREP CHG | CHLORHEXIDINE GLUCONATE | CLOTH;TOPICAL | 2% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 53329-244 | ReadyPrep CHG | Chlorhexidine gluconate 2% | Medline Industries | NDA | Current |
| 53329-244 | ReadyPrep CHG | Chlorhexidine gluconate 2% | Medline Industries | NDA | Current |
| 53329-244 | ReadyPrep CHG | Chlorhexidine gluconate 2% | Medline Industries, LP | NDA | Current |
| 53329-244 | ReadyPrep CHG | Chlorhexidine gluconate 2% | Medline Industries, LP | NDA | Current |
| 53329-244 | ReadyPrep CHG | Chlorhexidine gluconate 2% | Medline Industries, LP | NDA | Current |
| 53329-244 | ReadyPrep CHG | Chlorhexidine gluconate 2% | Medline Industries, LP | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74370 | SUPPL | 2023-05-25 |
| 74369 | SUPPL | 2023-05-25 |
| 58999 | ORIG | 2019-06-10 |
| 57114 | ORIG | 2019-01-31 |
| 56632 | ORIG | 2018-12-04 |