Application 090783
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No |
| 002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 30MG BASE | No | No |
| 003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 60MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7542 | Duloxetine | Duloxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7542 | Duloxetine | Duloxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7543 | Duloxetine | Duloxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7543 | Duloxetine | Duloxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7544 | Duloxetine | Duloxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7544 | Duloxetine | Duloxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 42708-021 | Duloxetine | Duloxetine | QPharma Inc | ANDA | Current |
| 42708-021 | Duloxetine | Duloxetine | QPharma Inc | ANDA | Current |
| 64725-7544 | Duloxetine | Duloxetine | TYA Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31494 | ORIG | 2013-12-13 |