Application 210599
- Type
- ANDA
- Sponsor
- QINGDAO BAHEAL PHARM
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70247-012 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-012 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-012 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-013 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-013 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-013 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-014 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-014 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |
| 70247-014 | NA | Duloxetine delayed-release capsules | Qingdao BAHEAL Pharmaceutical Co., Ltd. | ANDA | Current |