Application 203581
- Type
- ANDA
- Sponsor
- PHARMADAX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLYBURIDE | GLYBURIDE | TABLET;ORAL | 1.25MG | No | No |
| 002 | GLYBURIDE | GLYBURIDE | TABLET;ORAL | 2.5MG | No | No |
| 003 | GLYBURIDE | GLYBURIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4215 | glyBURIDE | glyBURIDE | A-S Medication Solutions | ANDA | Current |
| 52817-120 | glyBURIDE | glyBURIDE | TruPharma, LLC | ANDA | Current |
| 52817-120 | glyBURIDE | glyBURIDE | TruPharma, LLC | ANDA | Current |
| 52817-121 | glyBURIDE | glyBURIDE | TruPharma, LLC | ANDA | Current |
| 52817-121 | glyBURIDE | glyBURIDE | TruPharma, LLC | ANDA | Current |
| 52817-122 | glyBURIDE | glyBURIDE | TruPharma, LLC | ANDA | Current |
| 52817-122 | glyBURIDE | glyBURIDE | TruPharma, LLC | ANDA | Current |
| 55700-576 | glyBURIDE | glyBURIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 70518-1121 | glyBURIDE | glyBURIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1121 | glyBURIDE | glyBURIDE | REMEDYREPACK INC. | ANDA | Current |