Application 021924
- Type
- NDA
- Sponsor
- INSTITUT BIOCHIMIQUE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.025MG | Yes | No |
| 003 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.05MG | Yes | No |
| 004 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.075MG | Yes | No |
| 005 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.1MG | Yes | No |
| 006 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.125MG | Yes | No |
| 007 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.15MG | Yes | No |
| 008 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.112MG | Yes | No |
| 009 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.137MG | Yes | No |
| 010 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.088MG | Yes | No |
| 011 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.175MG | Yes | No |
| 012 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.200MG | Yes | Yes |
| 013 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.013MG | Yes | No |
| 014 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.0375MG | Yes | No |
| 015 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.044MG | Yes | No |
| 016 | TIROSINT | LEVOTHYROXINE SODIUM | CAPSULE;ORAL | 0.0625MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4951 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4952 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4953 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4954 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4955 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4956 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4957 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4958 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4959 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4960 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4961 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0527-4962 | Levothyroxine Sodium | levothyroxine sodium | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |
| 24090-490 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-491 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-492 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-493 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-494 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-495 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-496 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-497 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-498 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 24090-499 | Tirosint | Levothyroxine Sodium | Akrimax Pharmaceuticals, LLC | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0005 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0010 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0010 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
| 71858-0010 | Tirosint | levothyroxine sodium | IBSA Pharma Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72501 | SUPPL | 2022-10-31 |
| 72490 | SUPPL | 2022-10-28 |
| 50648 | SUPPL | 2017-12-11 |
| 6461 | SUPPL | 2012-03-12 |
| 37883 | SUPPL | 2012-03-06 |
| 42351 | ORIG | 2008-09-04 |
| 6460 | SUPPL | 2008-01-09 |
| 16576 | SUPPL | 2007-12-27 |
| 6459 | ORIG | 2006-10-23 |
| 16575 | ORIG | 2006-10-18 |