Skip to contentApplication 208295
- Type
- ANDA
- Sponsor
- WATSON LABS TEVA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ALVIMOPAN | ALVIMOPAN | CAPSULE;ORAL | 12MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2312 | Alvimopan | Alvimopan | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2312 | Alvimopan | Alvimopan | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2312 | Alvimopan | Alvimopan | Actavis Pharma, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83453 | SUPPL | 2025-09-25 |
| 76420 | ORIG | 2023-11-06 |
| 62184 | ORIG | 2020-03-18 |