Application 021301

Type: NDA
Sponsor: KING PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
002	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
003	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
004	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
005	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
006	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
007	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
008	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
009	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
010	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
011	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	Yes
012	LEVOXYL	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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	RLD / RS	Approval date
N021301-001	LEVOXYL	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-002	LEVOXYL	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-003	LEVOXYL	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-004	LEVOXYL	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-005	LEVOXYL	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-006	LEVOXYL	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-007	LEVOXYL	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-008	LEVOXYL	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-009	LEVOXYL	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-010	LEVOXYL	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25
N021301-011	LEVOXYL	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD, RS	2001-05-25
N021301-012	LEVOXYL	LEVOTHYROXINE SODIUM	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2001-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 22 matching rows.

Application-product, TE code table
Application-product	TE code
N021301-001	AB1
N021301-001	AB3
N021301-002	AB1
N021301-002	AB3
N021301-003	AB1
N021301-003	AB3
N021301-004	AB1
N021301-004	AB3
N021301-005	AB1
N021301-005	AB3
N021301-006	AB1
N021301-006	AB3
N021301-007	AB1
N021301-007	AB3
N021301-008	AB1
N021301-008	AB3
N021301-009	AB1
N021301-009	AB3
N021301-010	AB1
N021301-010	AB3
N021301-011	AB1
N021301-011	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021301-001	LEVOXYL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-002	LEVOXYL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-003	LEVOXYL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-004	LEVOXYL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-005	LEVOXYL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-006	LEVOXYL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-007	LEVOXYL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-008	LEVOXYL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-009	LEVOXYL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-010	LEVOXYL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-011	LEVOXYL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD, RS	2001-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-012	LEVOXYL	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2001-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-001	LEVOXYL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-002	LEVOXYL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-003	LEVOXYL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-004	LEVOXYL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-005	LEVOXYL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-006	LEVOXYL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-007	LEVOXYL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-008	LEVOXYL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-009	LEVOXYL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-010	LEVOXYL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-011	LEVOXYL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD, RS	2001-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-012	LEVOXYL	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2001-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021301-001	LEVOXYL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-002	LEVOXYL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-003	LEVOXYL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-004	LEVOXYL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-005	LEVOXYL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-006	LEVOXYL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-007	LEVOXYL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-008	LEVOXYL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-009	LEVOXYL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-010	LEVOXYL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-011	LEVOXYL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD, RS	2001-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021301-012	LEVOXYL	0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2001-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021301-001	LEVOXYL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021301-002	LEVOXYL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021301-003	LEVOXYL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021301-004	LEVOXYL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB3	RLD	2001-05-25	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 23 · 902 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	N021301-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-001	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-002	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-003	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-004	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-005	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-006	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-007	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-008	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-009	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-010	AB3	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-011	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021301-011	AB3	2	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-001	AB3	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-002	AB3	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-003	AB3	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-004	AB3	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-005	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-005	AB3	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-006	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-006	AB3	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-007	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-007	AB3	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-008	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-008	AB3	2	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-009	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021301-009	AB3	2	`31067a03dcf5…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 720 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-001	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-001	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-001	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-002	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-002	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-002	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-003	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-003	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-003	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-004	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-004	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-004	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-005	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-005	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-005	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-006	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-006	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-006	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-007	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-007	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-007	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-008	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-008	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-008	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-009	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-009	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-009	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-010	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-010	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-010	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-011	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-011	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-011	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-012	6555581	2022-02-15			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-012	7067148	2022-02-15		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021301-012	7101569	2023-10-02	U-759		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021301-001	6555581	2022-02-15			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021301-001	7067148	2022-02-15		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021301-001	7101569	2023-10-02	U-759		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021301-002	6555581	2022-02-15			`5d02ea3f76ae…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVOXYL	LEVOTHYROXINE SODIUM	Pfizer Laboratories Div Pfizer Inc	758588c3-c63e-491b-0aa2-4f50d80cb174	2020-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021301 application number: NDA021301 ndc (product): 60793-853 ndc (product): 60793-852 ndc (product): 60793-850 ndc (product): 60793-855 ndc (product): 60793-857 ndc (product): 60793-859 ndc (product): 60793-854 ndc (product): 60793-860 ndc (product): 60793-851 ndc (product): 60793-856 ndc (product): 60793-858

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60793-850	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-850	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-850	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-851	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-851	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-851	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-852	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-852	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-852	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-853	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-853	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-853	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-854	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-854	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-854	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-855	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-855	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-855	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-856	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-856	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-856	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-857	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-857	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-857	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-858	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-858	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-858	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-859	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-859	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-859	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-860	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-860	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-860	LEVOXYL	levothyroxine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
66336-600	LEVOXYL	LEVOTHYROXINE SODIUM	Dispensing Solutions, Inc.	NDA	Current
66336-601	LEVOXYL	LEVOTHYROXINE SODIUM	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56986	SUPPL	2018-12-21
15135	SUPPL	2011-03-21
21581	SUPPL	2011-02-15
4964	SUPPL	2008-07-10
15134	SUPPL	2008-07-09
36610	SUPPL	2005-03-10
27416	SUPPL	2005-03-10
27415	SUPPL	2003-08-06
4963	SUPPL	2002-07-17
21580	ORIG	2002-01-07
36609	ORIG	2001-05-25
4962	ORIG	2001-05-25