Application 021342
- Type
- NDA
- Sponsor
- CEDIPROF INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 002 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 003 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 004 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 005 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 006 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 007 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 008 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 009 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 010 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 011 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 012 | LEVO-T | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-3280 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3281 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3282 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3283 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3284 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3285 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3286 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3287 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3288 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3289 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3290 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0527-3291 | Levothyroxine Sodium | Levothyroxine Sodium | Lannett Company, Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5180 | Levothyroxine Sodium | Levothyroxine Sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5180 | Levothyroxine Sodium | Levothyroxine Sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5180 | Levothyroxine Sodium | Levothyroxine Sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5180 | Levothyroxine Sodium | Levothyroxine Sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5181 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5181 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5181 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5181 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5182 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5182 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5182 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5182 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5183 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5183 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5183 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5183 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5184 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5184 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5184 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5184 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5185 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5185 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5185 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5185 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5186 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5186 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5186 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5186 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5187 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5187 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5187 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5187 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5188 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5188 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5188 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5188 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5189 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5189 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5189 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5189 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5190 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5190 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5190 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5190 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5191 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5191 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5191 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 0781-5191 | Levothyroxine sodium | Levothyroxine sodium | Sandoz Inc. | NDA AUTHORIZED GENERIC | Current |
| 33261-337 | Levothyroxine sodium | Levothyroxine sodium | Aidarex Pharmaceuticals LLC | NDA | Current |
| 35356-933 | Levothyroxine sodium | Levothyroxine sodium | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-955 | Levothyroxine sodium | Levothyroxine sodium | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 43353-296 | Levothyroxine sodium | Levothyroxine sodium | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 50090-0901 | Levothyroxine sodium | Levothyroxine sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5644 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5651 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5653 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5654 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5655 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5658 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5661 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5669 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5821 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5887 | Levothyroxine Sodium | Levothyroxine Sodium | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50436-5181 | Levothyroxine sodium | Levothyroxine sodium | Unit Dose Services | NDA AUTHORIZED GENERIC | Current |
| 50436-5182 | Levothyroxine sodium | Levothyroxine sodium | Unit Dose Services | NDA AUTHORIZED GENERIC | Current |
| 50436-5183 | Levothyroxine sodium | Levothyroxine sodium | Unit Dose Services | NDA AUTHORIZED GENERIC | Current |
| 51655-091 | Levothyroxine | Levothyroxine | Northwind Pharmaceuticals, LLC | NDA | Current |
| 51655-095 | Levothyroxine Sodium | Levothyroxine Sodium | Northwind Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85838 | SUPPL | 2026-05-21 |
| 85864 | SUPPL | 2026-05-11 |
| 50625 | SUPPL | 2017-12-07 |
| 50624 | SUPPL | 2017-12-07 |
| 27524 | SUPPL | 2011-03-11 |
| 15222 | SUPPL | 2009-06-22 |
| 27523 | SUPPL | 2009-06-17 |
| 27522 | SUPPL | 2008-06-13 |
| 27521 | SUPPL | 2008-06-13 |
| 36694 | SUPPL | 2008-06-12 |
| 15221 | SUPPL | 2008-06-12 |
| 42112 | SUPPL | 2005-05-13 |
| 42111 | SUPPL | 2005-05-13 |
| 5088 | SUPPL | 2004-06-24 |
| 5087 | SUPPL | 2004-06-24 |
| 36692 | SUPPL | 2003-12-11 |
| 5085 | SUPPL | 2003-12-11 |
| 36693 | SUPPL | 2003-08-28 |
| 5086 | SUPPL | 2003-08-28 |
| 69369 | ORIG | 2002-06-19 |
| 21609 | ORIG | 2002-06-19 |
| 27520 | ORIG | 2002-03-01 |
| 15220 | ORIG | 2002-03-01 |