Application 078745
- Type
- ANDA
- Sponsor
- CHARTWELL MOLECULAR
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RAMIPRIL | RAMIPRIL | CAPSULE;ORAL | 1.25MG | No | No |
| 002 | RAMIPRIL | RAMIPRIL | CAPSULE;ORAL | 2.5MG | No | No |
| 003 | RAMIPRIL | RAMIPRIL | CAPSULE;ORAL | 5MG | No | No |
| 004 | RAMIPRIL | RAMIPRIL | CAPSULE;ORAL | 10MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-271 | Ramipril | Ramipril | Camber Pharmaceuticals | ANDA | Current |
| 31722-272 | Ramipril | Ramipril | Camber Pharmaceuticals | ANDA | Current |
| 31722-273 | Ramipril | Ramipril | Camber Pharmaceuticals | ANDA | Current |
| 31722-274 | Ramipril | Ramipril | Camber Pharmaceuticals | ANDA | Current |
| 42291-692 | Ramipril | Ramipril | AvKARE, Inc. | ANDA | Current |
| 62135-271 | Ramipril | Ramipril | Chartwell RX, LLC. | ANDA | Current |
| 62135-271 | Ramipril | Ramipril | Chartwell RX, LLC. | ANDA | Current |
| 62135-272 | Ramipril | Ramipril | Chartwell RX, LLC. | ANDA | Current |
| 62135-272 | Ramipril | Ramipril | Chartwell RX, LLC. | ANDA | Current |
| 62135-273 | Ramipril | Ramipril | Chartwell RX, LLC. | ANDA | Current |
| 62135-273 | Ramipril | Ramipril | Chartwell RX, LLC. | ANDA | Current |
| 62135-274 | Ramipril | Ramipril | Chartwell RX, LLC. | ANDA | Current |
| 62135-274 | Ramipril | Ramipril | Chartwell RX, LLC. | ANDA | Current |
| 76282-271 | Ramipril | Ramipril | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-272 | Ramipril | Ramipril | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-273 | Ramipril | Ramipril | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-274 | Ramipril | Ramipril | Exelan Pharmaceuticals, Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 44395 | ORIG | 2008-07-01 |