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 1.

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 · 492 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
2026-02-19 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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 36 · 1,428 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209713-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-011	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-011	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-011	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-012	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-012	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209713-012	AB3	3	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-001	AB2	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-001	AB3	3	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209713-002	AB1	1	`31067a03dcf5…`

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 1 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	Coupler LLC	55f4c679-86cb-b97f-e063-6294a90ad5ef	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	55f67831-4680-edbf-e063-6294a90a1d36	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	544d67eb-8487-cb5d-e063-6394a90a3110	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	53e84179-fe2a-5696-e063-6394a90a8566	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	53316e75-9897-4935-e063-6294a90a94cf	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	c8ae9dc4-836f-4912-80d7-684fd374f40a	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	52cce695-4363-8a2c-e063-6294a90a1bbf	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	52cd19e4-a4b3-ecee-e063-6394a90ac33b	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	51b68266-95d2-c166-e063-6294a90a534f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	50fe00b3-6610-1cac-e063-6294a90af8ac	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	5100c561-0028-a3c0-e063-6394a90addeb	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	f94a81e2-49cd-430a-acda-1a47d5c5b59b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	0235176b-ec39-44c4-a9e1-e0729a7989fa	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	7d07e932-7372-4c17-aa53-55087107fa52	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	2ecaa38f-8a6f-4536-8033-251d2c52ae64	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	991399a4-ff94-44d0-b1ba-1f89e7759498	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	87333260-fe57-4d99-886c-7c66cb063898	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	99df68ea-4de7-4825-a6d7-894c70d01c28	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	4f26f9dc-cf49-4b55-a6f7-f2f579893ee4	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	ffc34bc6-5de5-addb-e053-6294a90a25be	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209713 application number: ANDA209713

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