Application 021402

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
002	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
003	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
004	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
005	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
006	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
007	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
008	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
009	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
010	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
011	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	Yes
012	SYNTHROID	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No

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

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
N021402-001	SYNTHROID	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-002	SYNTHROID	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-003	SYNTHROID	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-004	SYNTHROID	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-005	SYNTHROID	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-006	SYNTHROID	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-007	SYNTHROID	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-008	SYNTHROID	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-009	SYNTHROID	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-010	SYNTHROID	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24
N021402-011	SYNTHROID	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD, RS	2002-07-24
N021402-012	SYNTHROID	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 24 matching rows.

Application-product, TE code table
Application-product	TE code
N021402-001	AB1
N021402-001	AB2
N021402-002	AB1
N021402-002	AB2
N021402-003	AB1
N021402-003	AB2
N021402-004	AB1
N021402-004	AB2
N021402-005	AB1
N021402-005	AB2
N021402-006	AB1
N021402-006	AB2
N021402-007	AB1
N021402-007	AB2
N021402-008	AB1
N021402-008	AB2
N021402-009	AB1
N021402-009	AB2
N021402-010	AB1
N021402-010	AB2
N021402-011	AB1
N021402-011	AB2
N021402-012	AB1
N021402-012	AB2

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 · 516 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
2026-09-14 22:38:34	2026-08	N021402-001	SYNTHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-002	SYNTHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-003	SYNTHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-004	SYNTHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-005	SYNTHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-006	SYNTHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-007	SYNTHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-008	SYNTHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-009	SYNTHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-010	SYNTHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-011	SYNTHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD, RS	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-012	SYNTHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021402-001	SYNTHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-002	SYNTHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-003	SYNTHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-004	SYNTHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-005	SYNTHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-006	SYNTHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-007	SYNTHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-008	SYNTHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-009	SYNTHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-010	SYNTHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-011	SYNTHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD, RS	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-012	SYNTHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021402-001	SYNTHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-002	SYNTHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-003	SYNTHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-004	SYNTHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-005	SYNTHROID	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-006	SYNTHROID	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-007	SYNTHROID	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-008	SYNTHROID	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-009	SYNTHROID	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-010	SYNTHROID	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-011	SYNTHROID	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD, RS	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021402-012	SYNTHROID	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021402-001	SYNTHROID	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021402-002	SYNTHROID	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021402-003	SYNTHROID	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021402-004	SYNTHROID	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2	RLD	2002-07-24	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 26 · 1,032 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021402-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-011	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-011	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-012	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021402-012	AB2	2	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021402-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-001	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-002	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-003	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-004	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-004	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-005	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-005	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-006	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-006	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-007	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-007	AB2	2	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-008	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021402-008	AB2	2	`caaa826d4ba7…`

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
Synthroid	LEVOTHYROXINE SODIUM	AbbVie Inc.	1e11ad30-1041-4520-10b0-8f9d30d30fcc	2024-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021402 application number: NDA021402 ndc (product): 0074-9296

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 107 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-9296	Synthroid	Levothyroxine Sodium	AbbVie Inc.	NDA	Current
0074-9296	Synthroid	Levothyroxine Sodium	AbbVie Inc.	NDA	Current
0074-9296	Synthroid	Levothyroxine Sodium	AbbVie Inc.	NDA	Current
0074-9296	Synthroid	Levothyroxine Sodium	AbbVie Inc.	NDA	Current
43353-336	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
53808-0958	Synthroid	Levothyroxine Sodium	State of Florida DOH Central Pharmacy	NDA	Current
53808-1013	Synthroid	Levothyroxine Sodium	State of Florida DOH Central Pharmacy	NDA	Current
66336-340	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
66336-341	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
66336-342	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
66336-536	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
66336-537	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
66336-591	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
67544-061	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-883	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-884	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-885	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-886	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-887	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-888	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-889	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-890	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
67544-891	Synthroid	Levothyroxine Sodium	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
68258-5948	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
68258-5972	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
68258-5973	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current
68258-5974	Synthroid	Levothyroxine Sodium	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77586	SUPPL	2024-02-21
77590	SUPPL	2024-02-20
71979	SUPPL	2022-08-31
71974	SUPPL	2022-08-31
63965	SUPPL	2020-07-20
63938	SUPPL	2020-07-16
47414	SUPPL	2017-03-02
47413	SUPPL	2017-03-02
47325	SUPPL	2017-02-24
47324	SUPPL	2017-02-24
15373	SUPPL	2014-01-15
5258	SUPPL	2012-10-02
27675	SUPPL	2008-07-15
15372	SUPPL	2008-07-15
36822	SUPPL	2008-06-05
42138	ORIG	2002-11-25
27674	ORIG	2002-07-24
15371	ORIG	2002-07-24