Application 090432
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 003 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | TABLET;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42708-077 | Escitalopram | Escitalopram Oxalate | QPharma Inc | ANDA | Current |
| 42708-077 | Escitalopram | Escitalopram Oxalate | QPharma Inc | ANDA | Current |
| 50090-5131 | Escitalopram | Escitalopram Oxalate | A-S Medication Solutions | ANDA | Current |
| 50090-6025 | Escitalopram | Escitalopram Oxalate | A-S Medication Solutions | ANDA | Current |
| 55154-6649 | Escitalopram | Escitalopram Oxalate | Cardinal Health | ANDA | Current |
| 55154-6649 | Escitalopram | Escitalopram Oxalate | Cardinal Health | ANDA | Current |
| 57237-092 | Escitalopram | Escitalopram Oxalate | Citron Pharma LLC | ANDA | Current |
| 57237-093 | Escitalopram | Escitalopram Oxalate | Citron Pharma LLC | ANDA | Current |
| 57237-094 | Escitalopram | Escitalopram Oxalate | Citron Pharma LLC | ANDA | Current |
| 65862-373 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-373 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-373 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-373 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-373 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-374 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-374 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-374 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-374 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-374 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-375 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-375 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-375 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-375 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-375 | Escitalopram | Escitalopram Oxalate | Aurobindo Pharma Limited | ANDA | Current |
| 68071-2597 | Escitalopram | Escitalopram Oxalate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4484 | Escitalopram | Escitalopram Oxalate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-617 | Escitalopram | Escitalopram Oxalate | American Health Packaging | ANDA | Current |
| 68084-617 | Escitalopram | Escitalopram Oxalate | American Health Packaging | ANDA | Current |
| 68084-617 | Escitalopram | Escitalopram Oxalate | American Health Packaging | ANDA | Current |
| 68084-617 | Escitalopram | Escitalopram Oxalate | American Health Packaging | ANDA | Current |
| 68084-618 | Escitalopram | Escitalopram Oxalate | American Health Packaging | ANDA | Current |
| 68084-618 | Escitalopram | Escitalopram Oxalate | American Health Packaging | ANDA | Current |
| 68084-618 | Escitalopram | Escitalopram Oxalate | American Health Packaging | ANDA | Current |
| 68084-618 | Escitalopram | Escitalopram Oxalate | American Health Packaging | ANDA | Current |
| 68788-9456 | Escitalopram | Escitalopram Oxalate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9714 | Escitalopram | Escitalopram Oxalate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1103 | Escitalopram | Escitalopram Oxalate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1103 | Escitalopram | Escitalopram Oxalate | REMEDYREPACK INC. | ANDA | Current |
| 71205-168 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71205-168 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71205-168 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71205-168 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71205-193 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71205-193 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71205-193 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71205-193 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71205-193 | Escitalopram | Escitalopram Oxalate | Proficient Rx LP | ANDA | Current |
| 71335-0658 | Escitalopram | Escitalopram Oxalate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0658 | Escitalopram | Escitalopram Oxalate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0658 | Escitalopram | Escitalopram Oxalate | Bryant Ranch Prepack | ANDA | Current |