Application 204343
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
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 |
|---|
| 31722-168 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-168 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-169 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-169 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-170 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-170 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-581 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-582 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-583 | Duloxetine | Duloxetine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-4708 | Duloxetine | Duloxetine | A-S Medication Solutions | ANDA | Current |
| 50090-4709 | Duloxetine | Duloxetine | A-S Medication Solutions | ANDA | Current |
| 50090-6040 | Duloxetine | Duloxetine | A-S Medication Solutions | ANDA | Current |
| 50268-269 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-269 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-270 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-270 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-271 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-271 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-286 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-286 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-287 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-287 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-288 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 50268-288 | Duloxetine | Duloxetine | AvPAK | ANDA | Current |
| 68071-2709 | Duloxetine | Duloxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 80175-0582 | duloxetine | duloxetine | Central Packaging | ANDA | Current |
| 80175-0582 | duloxetine | duloxetine | Central Packaging | ANDA | Current |
| 80175-0582 | duloxetine | duloxetine | Central Packaging | ANDA | Current |
| 80175-0583 | duloxetine | duloxetine | Central Packaging | ANDA | Current |