Application 021116
- Type
- NDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 002 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 003 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 004 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 005 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 006 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 007 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 008 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 009 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 010 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 011 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | Yes | No |
| 012 | THYRO-TABS | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG **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 |
|---|---|---|---|---|---|
| 47781-640 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-640 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-640 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-640 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-643 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-643 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-643 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-643 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-646 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-646 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-646 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-646 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-649 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-649 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-649 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-649 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-651 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-651 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-651 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-651 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-654 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-654 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-654 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-654 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-657 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-657 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-657 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-657 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-659 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-659 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-659 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-659 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-662 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-662 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-662 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-662 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-665 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-665 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-665 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-665 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-668 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-668 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-668 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-668 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-671 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-671 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-671 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 47781-671 | levothyroxine sodium | levothyroxine sodium | Alvogen, Inc. | NDA | Current |
| 50090-4623 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4623 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4624 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4624 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4624 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4625 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4625 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4625 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4667 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4667 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4668 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4668 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4668 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4669 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4670 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4670 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4670 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4686 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4686 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4688 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4688 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4719 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4719 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4799 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4799 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4799 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-4899 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-5176 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 50090-5176 | levothyroxine sodium | levothyroxine sodium | A-S Medication Solutions | NDA | Current |
| 51655-723 | levothyroxine sodium | levothyroxine sodium | Northwind Pharmaceuticals, LLC | NDA | Current |
| 63629-8711 | levothyroxine sodium | levothyroxine sodium | Bryant Ranch Prepack | NDA | Current |
| 63629-8711 | levothyroxine sodium | levothyroxine sodium | Bryant Ranch Prepack | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76615 | SUPPL | 2023-11-17 |
| 76605 | SUPPL | 2023-11-17 |
| 74880 | SUPPL | 2023-07-25 |
| 70769 | SUPPL | 2022-04-15 |
| 69583 | SUPPL | 2021-12-16 |
| 58431 | SUPPL | 2019-04-26 |
| 58413 | SUPPL | 2019-04-25 |
| 49659 | SUPPL | 2017-09-01 |
| 49658 | SUPPL | 2017-09-01 |
| 26809 | SUPPL | 2016-05-24 |
| 4372 | SUPPL | 2006-03-23 |
| 36152 | SUPPL | 2006-03-14 |
| 21458 | ORIG | 2004-08-10 |
| 36151 | ORIG | 2002-10-24 |
| 26808 | ORIG | 2002-10-24 |