Application 017656
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACETIC ACID 0.25% IN PLASTIC CONTAINER | ACETIC ACID, GLACIAL | SOLUTION;IRRIGATION, URETHRAL | 250MG/100ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-6143 | Acetic Acid | Acetic Acid | Hospira, Inc. | NDA | Current |
| 0409-6143 | Acetic Acid | Acetic Acid | Hospira, Inc. | NDA | Current |
| 0990-6143 | Acetic Acid | Acetic Acid | ICU Medical Inc. | NDA | Current |
| 0990-6143 | Acetic Acid | Acetic Acid | ICU Medical Inc. | NDA | Current |
| 0990-6143 | Acetic Acid | Acetic Acid | ICU Medical Inc. | NDA | Current |
| 0990-6143 | Acetic Acid | Acetic Acid | ICU Medical Inc. | NDA | Current |