Skip to contentApplication 076665
- Type
- ANDA
- Sponsor
- CHARTWELL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 50MG | No | No |
| 002 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 100MG | No | No |
| 003 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 150MG | No | No |
| 004 | FLUCONAZOLE | FLUCONAZOLE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62135-130 | FLUCONAZOLE | FLUCONAZOLE | Chartwell RX, LLC | ANDA | Current |
| 62135-131 | FLUCONAZOLE | FLUCONAZOLE | Chartwell RX, LLC | ANDA | Current |
| 62135-132 | FLUCONAZOLE | FLUCONAZOLE | Chartwell RX, LLC | ANDA | Current |
| 62135-133 | FLUCONAZOLE | FLUCONAZOLE | Chartwell RX, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31153 | ORIG | 2004-07-30 |