Application 216370
- Type
- ANDA
- Sponsor
- ALEMBIC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
| 012 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216370-001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-004 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-005 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-006 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-007 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-008 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-009 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-010 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-011 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | |
| A216370-012 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216370-001 | AB2 |
| A216370-002 | AB2 |
| A216370-003 | AB2 |
| A216370-004 | AB2 |
| A216370-005 | AB2 |
| A216370-006 | AB2 |
| A216370-007 | AB2 |
| A216370-008 | AB2 |
| A216370-009 | AB2 |
| A216370-010 | AB2 |
| A216370-011 | AB2 |
| A216370-012 | AB2 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A216370-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A216370-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216370-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-001 | LEVOTHYROXINE SODIUM | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-002 | LEVOTHYROXINE SODIUM | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-003 | LEVOTHYROXINE SODIUM | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-004 | LEVOTHYROXINE SODIUM | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-005 | LEVOTHYROXINE SODIUM | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-006 | LEVOTHYROXINE SODIUM | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-007 | LEVOTHYROXINE SODIUM | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-008 | LEVOTHYROXINE SODIUM | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-009 | LEVOTHYROXINE SODIUM | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-010 | LEVOTHYROXINE SODIUM | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-011 | LEVOTHYROXINE SODIUM | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-012 | LEVOTHYROXINE SODIUM | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET / ORAL | AB2 | 2026-05-20 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A216370-001 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-002 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-003 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-004 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-005 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-006 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-007 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-008 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-009 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-010 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-011 | AB2 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A216370-012 | AB2 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-001 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-002 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-003 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-004 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-005 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-006 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-007 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-008 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-009 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-010 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-011 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216370-012 | AB2 | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-001 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-002 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-003 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-004 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-005 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-006 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-007 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-008 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-009 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-010 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-011 | AB2 | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216370-012 | AB2 | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Unithroid | LEVOTHYROXINE SODIUM | Amneal Pharmaceuticals LLC | 07562e72-7eaa-4ce6-94f0-e08814787e50 | 2019-06-19 | Boxed warning, Warnings, Adverse reactions | LEVOTHYROXINE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.