Application 078191
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55111-438 | Ramipril | Ramipril | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-438 | Ramipril | Ramipril | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-439 | Ramipril | Ramipril | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-439 | Ramipril | Ramipril | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-440 | Ramipril | Ramipril | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-440 | Ramipril | Ramipril | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-441 | Ramipril | Ramipril | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-441 | Ramipril | Ramipril | Dr. Reddy's Laboratories Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44376 | ORIG | 2008-07-01 |