Application 090723
- Type
- ANDA
- Sponsor
- MARKSANS PHARMA
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 |
|---|---|---|---|---|---|
| 25000-608 | Duloxetine | Duloxetine Hydrochloride | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-609 | Duloxetine | Duloxetine Hydrochloride | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-610 | Duloxetine | Duloxetine Hydrochloride | MARKSANS PHARMA LIMITED | ANDA | Current |
| 45865-813 | Duloxetine | Duloxetine | Medsource Pharmaceuticals | ANDA | Current |
| 45865-813 | Duloxetine | Duloxetine | Medsource Pharmaceuticals | ANDA | Current |
| 45865-816 | Duloxetine | Duloxetine | Medsource Pharmaceuticals | ANDA | Current |
| 45865-816 | Duloxetine | Duloxetine | Medsource Pharmaceuticals | ANDA | Current |
| 68788-9266 | Duloxetine | Duloxetine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9287 | ORIG | 2013-12-13 |