Application 079150
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUCONAZOLE | FLUCONAZOLE | FOR SUSPENSION;ORAL | 50MG/5ML | No | No |
| 002 | FLUCONAZOLE | FLUCONAZOLE | FOR SUSPENSION;ORAL | 200MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-695 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-695 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-695 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-695 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-695 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-695 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-695 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-696 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-696 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-696 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-696 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-696 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-696 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 16714-696 | Fluconazole | Fluconazole | NorthStar Rx LLC | ANDA | Current |
| 57237-149 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-149 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-149 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-149 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-149 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-149 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-149 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-149 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-150 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-150 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-150 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-150 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-150 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-150 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-150 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 57237-150 | Fluconazole | Fluconazole | Rising Health, LLC | ANDA | Current |
| 65862-299 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-299 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-299 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-299 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-299 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-299 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-300 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-300 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-300 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-300 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-300 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-300 | Fluconazole | Fluconazole | Aurobindo Pharma Limited | ANDA | Current |