Application 209920
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LUBIPROSTONE | LUBIPROSTONE | CAPSULE;ORAL | 8MCG | No | No |
| 002 | LUBIPROSTONE | LUBIPROSTONE | CAPSULE;ORAL | 24MCG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0480-3479 | Lubiprostone | Lubiprostone | Teva Pharmaceuticals, Inc. | ANDA | Current |
| 0480-4138 | Lubiprostone | Lubiprostone | Teva Pharmaceuticals, Inc. | ANDA | Current |
| 72189-410 | Amitza | Lubiprostone | Direct_Rx | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67035 | ORIG | 2021-04-13 |