Application 206483
- Type
- ANDA
- Sponsor
- ORIENT PHARMA CO LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0121-0929 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0929 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0929 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0929 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0930 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0930 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0930 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0930 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0931 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0931 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0931 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0931 | Glyburide | Glyburide | Pharmaceutical Associates, Inc. | ANDA | Current |
| 68071-2402 | Glyburide | Glyburide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7970 | Glyburide | Glyburide | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7970 | Glyburide | Glyburide | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 76333-154 | Glyburide | Glyburide | Orient Pharma Co., Ltd. | ANDA | Current |
| 76333-155 | Glyburide | Glyburide | Orient Pharma Co., Ltd. | ANDA | Current |
| 76333-156 | Glyburide | Glyburide | Orient Pharma Co., Ltd. | ANDA | Current |