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 6 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	ffc34bc6-5de5-addb-e053-6294a90a25be	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	49136b34-1bc1-ec4e-e063-6394a90ac9dd	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f2bed4e7-86e9-430e-80d9-7bd7cfcf9bf5	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	8f7dc71e-4a48-4ba5-945b-f340ff51636e	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	36af0286-e447-4098-b3f2-772debd58667	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	e8142948-2bde-4f4b-931e-da43e91f2d59	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	d29bc0fd-5587-4a70-a505-f5aee1f115a6	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	d5b11dac-1acd-4aa2-b837-e3b90d4f6922	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f6c92836-95e1-1402-e053-6394a90a2f5e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	e2291336-1188-48f4-af52-d12ac892f80f	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	98d7ce2b-a248-4ed0-a2ec-d28ba623531e	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	59a99739-2da5-46a7-8811-1169123bed9b	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	579b1935-77f5-4381-9cb0-e0130e4834e8	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	4e6dce46-cbf5-4353-9d0c-36b6f857197a	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Lannett Company, Inc	a8db0f7d-8863-9309-e053-2995a90a284a	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	3d737f79-7fc9-4221-e063-6394a90ac9aa	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	c968836a-f94c-4d13-e053-2995a90a8df5	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	db10e666-6204-56cc-e053-2995a90a9e08	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	db5dd9d2-4f96-25d0-e053-2995a90af9dc	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	c9f4923e-5625-1d4f-e053-2a95a90aabc9	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