Application 204774
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 75MG | No | No |
| 002 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 150MG | No | No |
| 003 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-160 | Irbesartan | Irbesartan | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-161 | Irbesartan | Irbesartan | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-162 | Irbesartan | Irbesartan | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50228-160 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-160 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-160 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-161 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-161 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-161 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-162 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-162 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-162 | Irbesartan | Irbesartan | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 60429-640 | Irbesartan | Irbesartan | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-640 | Irbesartan | Irbesartan | Golden State Medical Supply | ANDA | Current |
| 60429-641 | Irbesartan | Irbesartan | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-641 | Irbesartan | Irbesartan | Golden State Medical Supply | ANDA | Current |
| 60429-642 | Irbesartan | Irbesartan | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-642 | Irbesartan | Irbesartan | Golden State Medical Supply | ANDA | Current |
| 69367-119 | Irbesartan | Irbesartan | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-119 | Irbesartan | Irbesartan | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-120 | Irbesartan | Irbesartan | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-120 | Irbesartan | Irbesartan | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-121 | Irbesartan | Irbesartan | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-121 | Irbesartan | Irbesartan | Westminster Pharmaceuticals, LLC | ANDA | Current |