Application 206530
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 20MG | No | No |
| 002 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 40MG | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-3888 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 50090-3888 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 50090-3888 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 50090-5241 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 50090-5241 | Famotidine | Famotidine | A-S Medication Solutions | ANDA | Current |
| 53002-2199 | Famotidine | Famotidine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-6670 | Famotidine | Famotidine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-6670 | Famotidine | Famotidine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 58118-0859 | Famotidine | Famotidine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0859 | Famotidine | Famotidine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0859 | Famotidine | Famotidine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60687-595 | Famotidine | Famotidine | American Health Packaging | ANDA | Current |
| 60687-595 | Famotidine | Famotidine | American Health Packaging | ANDA | Current |
| 65862-859 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-859 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-859 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-859 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-859 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-859 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-860 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-860 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-860 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-860 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-860 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-860 | Famotidine | Famotidine | Aurobindo Pharma Limited | ANDA | Current |
| 67296-1776 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1776 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1795 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1795 | Famotidine | Famotidine | RedPharm Drug, Inc. | ANDA | Current |
| 68001-397 | Famotidine | Famotidine | BluePoint Laboratories | ANDA | Current |
| 68001-397 | Famotidine | Famotidine | BluePoint Laboratories | ANDA | Current |
| 68001-398 | Famotidine | Famotidine | BluePoint Laboratories | ANDA | Current |
| 68001-398 | Famotidine | Famotidine | BluePoint Laboratories | ANDA | Current |
| 68071-1879 | Famotidine | Famotidine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 70518-3301 | Famotidine | Famotidine | REMEDYREPACK INC. | ANDA | Current |
| 70934-814 | Famotidine | Famotidine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-535 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 71205-535 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 71205-535 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 71205-634 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 71205-634 | Famotidine | Famotidine | Proficient Rx LP | ANDA | Current |
| 71335-0370 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0370 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0370 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 32814 | ORIG | 2015-12-30 |