Application 207219
- Type
- ANDA
- Sponsor
- YAOPHARMA CO LTD
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 |
|---|---|---|---|---|---|
| 50771-201 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-201 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-202 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-202 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-203 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-203 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |