Application 211369

Type: ANDA
Sponsor: TEVA PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.075MG	No	No
002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.15MG	No	No
003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.112MG	No	No
004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.200MG	No	No
005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.137MG	No	No
006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.175MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A211369-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	2020-10-28
A211369-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	2020-10-28
A211369-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	2021-04-16
A211369-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	2022-11-09
A211369-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE / ORAL	2023-05-02
A211369-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE / ORAL	2023-05-02

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 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211369-001	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	2020-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211369-002	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	2020-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211369-003	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	2021-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211369-004	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	2022-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211369-005	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE / ORAL	2023-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211369-006	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE / ORAL	2023-05-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211369-001	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	2020-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211369-002	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	2020-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211369-003	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	2021-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211369-004	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	2022-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211369-005	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE / ORAL	2023-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211369-006	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE / ORAL	2023-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211369-001	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211369-002	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211369-003	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	2021-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211369-004	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	2022-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211369-005	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE / ORAL	2023-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211369-006	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE / ORAL	2023-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211369-001	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	2020-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211369-002	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	2020-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211369-003	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	2021-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211369-004	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	2022-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211369-005	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE / ORAL	2023-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211369-006	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE / ORAL	2023-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211369-001	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	2020-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211369-002	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	2020-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211369-003	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	2021-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211369-004	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	2022-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211369-005	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE / ORAL	2023-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211369-006	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE / ORAL	2023-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211369-001	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	2020-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211369-002	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	2020-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211369-003	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	2021-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211369-004	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	2022-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211369-005	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE / ORAL	2023-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211369-006	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE / ORAL	2023-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211369-001	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	2020-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211369-002	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	2020-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211369-003	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	2021-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211369-004	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	2022-11-09	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A211369-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211369-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211369-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211369-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211369-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211369-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211369-002	AB	1	`8869cabd3fbd…`
2023-05-13 08:27 UTC	2023-05	A211369-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211369-004	AB	1	`3bdfa0b2c4d7…`

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 7 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db89c58f-9dd0-b6d6-e053-2a95a90ae2e7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	d9cb3417-e8cb-13f8-e053-2a95a90a294b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	ca4634a5-d8d7-48a4-e053-2995a90a0cd4	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	dac0af5d-622c-e18c-e053-2995a90a5739	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f317a597-4644-746a-e053-2995a90a807f	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	e0503b8c-7eb7-269e-e053-2995a90a1bca	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	e08c2af4-c20a-3176-e053-2a95a90a1aa9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	e3d949ce-731b-6dfe-e053-2a95a90a0074	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31b5d54-7536-4290-e053-2a95a90ac235	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f32b4a01-edea-fc85-e053-2995a90ac175	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db998119-a293-3568-e053-2995a90ac47a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	d9dfd5b8-06a5-2728-e053-2995a90a298e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	fa15ac73-f4f6-7a6b-e053-6294a90a4f4e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31a35cb-fc54-8872-e053-2a95a90ad8e7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31ba297-e042-187a-e053-2a95a90a4861	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f31d987d-6836-b4a7-e053-2a95a90a8f7b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86e74e1-0d55-8d0e-e053-6394a90a07bf	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86efc89-f784-c8bb-e053-6294a90a63c9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db9821db-3fe3-d1cf-e053-2a95a90a0252	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	da570872-94a1-4852-e053-2995a90aacb6	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65511	ORIG	2020-12-07