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 15 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unithroid	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals LLC	07562e72-7eaa-4ce6-94f0-e08814787e50	2019-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback 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