Application 206653
- Type
- ANDA
- Sponsor
- PRINSTON INC
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 |
|---|---|---|---|---|---|
| 43547-379 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-379 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-379 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-379 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-380 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-380 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-380 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-380 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-381 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-381 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-381 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-381 | DULOXETINE | Duloxetine | Solco Healthcare US, LLC | ANDA | Current |
| 70518-1128 | DULOXETINE | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1128 | DULOXETINE | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1128 | DULOXETINE | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1128 | DULOXETINE | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1128 | DULOXETINE | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3177 | DULOXETINE | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 71335-1964 | DULOXETINE | Duloxetine | Bryant Ranch Prepack | ANDA | Current |