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 2 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	A-S Medication Solutions	c8ae9dc4-836f-4912-80d7-684fd374f40a	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	52cce695-4363-8a2c-e063-6294a90a1bbf	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	52cd19e4-a4b3-ecee-e063-6394a90ac33b	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	db5cba81-9ad5-42ad-ac9e-a967337630f2	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d9ccea69-109d-44cf-927b-4ff67652b6a0	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	4f40db1e-3dd9-4c7b-93e6-64f0fd10d551	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	50978a14-fd72-4c76-927f-667a1f097b87	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	eb53dc23-8337-497e-b466-192f905563ed	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	6d65b528-f52b-4b5d-8b76-46fbd4576f99	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	3519c765-2077-4f23-8644-a6242ddbf743	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	c38c3c31-6834-4590-ace0-f525e5599f66	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	ac10b751-5195-4987-a841-400ae79730f0	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	83854522-f22e-491f-8392-c8b1f9441760	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	645c52bb-c46e-426e-91d4-151aeac975a7	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	65c8b305-8ffb-4aa5-aca1-f4e4ead71a9c	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	633b3f9c-9578-4e07-a515-aec1a8b65e92	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	0cffbc96-7a02-4538-9966-b69249be6eb2	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	e293dd94-b523-47a2-8bed-e6d99945ee59	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	776c8dbc-ca34-40f9-9730-4aa59f644703	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	5c1cf991-6177-499d-a9b8-63e5ca92eb79	2026-05-15	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