Application 090778
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|
| 0904-7043 | Duloxetine | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7043 | Duloxetine | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7044 | Duloxetine | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7044 | Duloxetine | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7044 | Duloxetine | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7045 | Duloxetine | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7045 | Duloxetine | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7045 | Duloxetine | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 42292-020 | Duloxetine | Duloxetine Hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 42292-021 | Duloxetine | Duloxetine Hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 43063-877 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-877 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-877 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-877 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-877 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-877 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-877 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-877 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-878 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-878 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-878 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-878 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-878 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-878 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-878 | Duloxetine | Duloxetine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-2585 | Duloxetine | Duloxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2585 | Duloxetine | Duloxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2844 | Duloxetine | Duloxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2844 | Duloxetine | Duloxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0018 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-0019 | Duloxetine | Duloxetine Hydrochloride | Unit Dose Services | ANDA | Current |
| 55154-2341 | Duloxetine | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-2342 | Duloxetine | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-079 | Duloxetine | Duloxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-080 | Duloxetine | Duloxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-017 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-017 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-017 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-017 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-017 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-017 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-017 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-018 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-018 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-018 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-018 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-018 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-018 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-018 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-019 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-019 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-019 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-019 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-019 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-019 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-019 | Duloxetine | Duloxetine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 59651-279 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-279 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-279 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-279 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-279 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-280 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-280 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-280 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-280 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-280 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-282 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-282 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-282 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-282 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-282 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 63187-612 | Duloxetine | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-612 | Duloxetine | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-666 | Duloxetine | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-666 | Duloxetine | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 65862-451 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-451 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-452 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-452 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-453 | Duloxetine | Duloxetine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9293 | ORIG | 2013-12-13 |