Application 209713

Type: ANDA
Sponsor: LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209713-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18
A209713-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 36 matching rows.

Application-product, TE code table
Application-product	TE code
A209713-001	AB1
A209713-001	AB2
A209713-001	AB3
A209713-002	AB1
A209713-002	AB2
A209713-002	AB3
A209713-003	AB1
A209713-003	AB2
A209713-003	AB3
A209713-004	AB1
A209713-004	AB2
A209713-004	AB3
A209713-005	AB1
A209713-005	AB2
A209713-005	AB3
A209713-006	AB1
A209713-006	AB2
A209713-006	AB3
A209713-007	AB1
A209713-007	AB2
A209713-007	AB3
A209713-008	AB1
A209713-008	AB2
A209713-008	AB3
A209713-009	AB1
A209713-009	AB2
A209713-009	AB3
A209713-010	AB1
A209713-010	AB2
A209713-010	AB3
A209713-011	AB1
A209713-011	AB2
A209713-011	AB3
A209713-012	AB1
A209713-012	AB2
A209713-012	AB3

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.

Product history page 1 of 13 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209713-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209713-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209713-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3	2019-01-18	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 38 · 1,500 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209713-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-011	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-012	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209713-012	AB3	3	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209713-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-001	AB3	3	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209713-002	AB1	1	`caaa826d4ba7…`

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.

Matched openFDA labels page 3 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	American Health Packaging	38af4e36-b26b-485d-a6f3-7fbcf6072a0f	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713 ndc (product): 60687-497 ndc (product): 60687-453 ndc (product): 60687-475 ndc (product): 60687-519 ndc (product): 60687-541 ndc (product): 60687-552 ndc (product): 60687-464 ndc (product): 60687-486 ndc (product): 60687-530 ndc (product): 60687-508 ndc (product): 60687-563
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f0680426-3581-400c-8ab5-5e6f18d0cabc	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	b4654497-c986-4792-9b6b-0a791c7c205b	2025-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	0e0ad9f1-1f52-48ce-a996-79ebe7ad53cd	2025-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	faaa1123-7515-46c2-abbb-b0615540c8cf	2025-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713 ndc (product): 50090-4947
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	7f8ec438-8ddf-45d2-be94-ac032e192229	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713 ndc (product): 50090-4951
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f5fc0f34-744c-4e03-ae9f-e017e4033139	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	30ccec8b-3f95-61c7-e063-6394a90a05a0	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Lupin Pharmaceuticals, Inc.	18717e58-89fb-4e2f-93b6-d6ac3e988d37	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713 ndc (product): 68180-965
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	f0a63075-631d-43bf-9d8e-df79faf0a278	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	2cf48978-d996-f5ba-e063-6294a90a8824	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	ddec2148-f97e-4a79-9943-4bef2386a7f2	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	27e98e6d-9fd7-3a94-e063-6394a90a1dcb	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	29bb8dbe-f8ba-e2ba-e063-6394a90af38c	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	a0ffe111-3574-4481-a732-b68a7d58ef71	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	2646a481-09a5-af6a-e063-6394a90a16da	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	924bb6e9-4b2b-406f-a0a8-376b1f22f1f5	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713 ndc (product): 50090-5792
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCarePharmaceuticals, Inc.	2380859a-5b65-f88f-e063-6394a90aa4e2	2024-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	DIRECT RX	a5f15022-1166-09fe-e053-2a95a90aa218	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	804d64c9-9804-4d6d-adb2-5036c0be8b5c	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 199 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6949	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6949	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6950	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6950	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6951	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6951	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6952	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6952	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6953	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6953	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6954	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6954	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6955	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6955	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6956	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6956	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6957	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
0904-6957	Levothyroxine Sodium	Levothyroxine Sodium	Major Pharmaceuticals	ANDA	Current
50090-4947	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-4947	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-4951	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-4951	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-5133	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
50090-5792	Levothyroxine Sodium	Levothyroxine Sodium	A-S Medication Solutions	ANDA	Current
51655-479	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals, LLC	ANDA	Current
51655-528	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals, LLC	ANDA	Current
51655-923	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	ANDA	Current
51655-924	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	ANDA	Current
51655-985	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	ANDA	Current
51655-989	Levothyroxine Sodium	Levothyroxine Sodium	Northwind Pharmaceuticals	ANDA	Current
55154-3558	Levothyroxine Sodium	Levothyroxine Sodium	Cardinal Health	ANDA	Current
55154-3559	Levothyroxine Sodium	Levothyroxine Sodium	Cardinal Health	ANDA	Current
55154-3560	Levothyroxine Sodium	Levothyroxine Sodium	Cardinal Health	ANDA	Current
55154-3561	Levothyroxine Sodium	Levothyroxine Sodium	Cardinal Health	ANDA	Current
55154-3562	Levothyroxine Sodium	Levothyroxine Sodium	Cardinal Health	ANDA	Current
55154-3563	Levothyroxine Sodium	Levothyroxine Sodium	Cardinal Health	ANDA	Current
60687-453	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-453	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-453	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-453	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-464	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-464	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-464	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-464	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-475	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-475	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-475	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-475	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-486	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-486	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-486	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-486	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-497	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-497	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-497	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-497	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-508	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-508	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-508	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-508	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-519	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-519	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-519	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-519	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-530	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-530	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-530	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-530	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-541	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-541	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-541	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-541	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-552	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-552	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-552	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-563	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-563	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
60687-563	Levothyroxine Sodium	Levothyroxine Sodium	American Health Packaging	ANDA	Current
68180-965	Levothyroxine Sodium	Levothyroxine Sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-965	Levothyroxine Sodium	Levothyroxine Sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71492	SUPPL	2022-06-30