Application 019824
- Type
- NDA
- Sponsor
- MEDIMETRIKS PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOPROX | CICLOPIROX | SUSPENSION;TOPICAL | 0.77% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43538-550 | Loprox | ciclopirox olamine | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-551 | Loprox | Ciclopirox Olamine | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 69315-309 | CICLOPIROX OLAMINE | CICLOPIROX OLAMINE | Leading Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 69315-309 | CICLOPIROX OLAMINE | CICLOPIROX OLAMINE | Leading Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84075 | SUPPL | 2025-11-05 |
| 84070 | SUPPL | 2025-11-05 |
| 33992 | SUPPL | 2013-07-11 |
| 1655 | SUPPL | 2013-07-02 |
| 33991 | SUPPL | 2003-03-28 |
| 19266 | SUPPL | 2003-03-28 |
| 11746 | SUPPL | 2003-03-28 |
| 1654 | SUPPL | 2003-03-28 |