Application 021402
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 002 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 003 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 004 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 005 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 006 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 007 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 008 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 009 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 010 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 011 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | Yes |
| 012 | SYNTHROID | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-3727 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4341 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-4552 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-5182 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6594 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-6624 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7068 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7069 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7070 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7148 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-7149 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-9296 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-9296 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
| 0074-9296 | Synthroid | Levothyroxine Sodium | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77586 | SUPPL | 2024-02-21 |
| 77590 | SUPPL | 2024-02-20 |
| 71979 | SUPPL | 2022-08-31 |
| 71974 | SUPPL | 2022-08-31 |
| 63965 | SUPPL | 2020-07-20 |
| 63938 | SUPPL | 2020-07-16 |
| 47414 | SUPPL | 2017-03-02 |
| 47413 | SUPPL | 2017-03-02 |
| 47325 | SUPPL | 2017-02-24 |
| 47324 | SUPPL | 2017-02-24 |
| 15373 | SUPPL | 2014-01-15 |
| 5258 | SUPPL | 2012-10-02 |
| 27675 | SUPPL | 2008-07-15 |
| 15372 | SUPPL | 2008-07-15 |
| 36822 | SUPPL | 2008-06-05 |
| 42138 | ORIG | 2002-11-25 |
| 27674 | ORIG | 2002-07-24 |
| 15371 | ORIG | 2002-07-24 |