Application 021292

Type: NDA
Sponsor: PROVELL

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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	Approval date
N021292-001	EUTHYROX	LEVOTHYROXINE SODIUM	0.025MG	TABLET / ORAL	2002-05-31
N021292-002	EUTHYROX	LEVOTHYROXINE SODIUM	0.05MG	TABLET / ORAL	2002-05-31
N021292-003	EUTHYROX	LEVOTHYROXINE SODIUM	0.075MG	TABLET / ORAL	2002-05-31
N021292-004	EUTHYROX	LEVOTHYROXINE SODIUM	0.088MG	TABLET / ORAL	2002-05-31
N021292-005	EUTHYROX	LEVOTHYROXINE SODIUM	0.1MG	TABLET / ORAL	2002-05-31
N021292-006	EUTHYROX	LEVOTHYROXINE SODIUM	0.112MG	TABLET / ORAL	2002-05-31
N021292-007	EUTHYROX	LEVOTHYROXINE SODIUM	0.125MG	TABLET / ORAL	2002-05-31
N021292-008	EUTHYROX	LEVOTHYROXINE SODIUM	0.137MG	TABLET / ORAL	2002-05-31
N021292-009	EUTHYROX	LEVOTHYROXINE SODIUM	0.15MG	TABLET / ORAL	2002-05-31
N021292-010	EUTHYROX	LEVOTHYROXINE SODIUM	0.175MG	TABLET / ORAL	2002-05-31
N021292-011	EUTHYROX	LEVOTHYROXINE SODIUM	0.2MG	TABLET / ORAL	2002-05-31
N021292-012	EUTHYROX	LEVOTHYROXINE SODIUM	0.3MG	TABLET / ORAL	2002-05-31

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 14 · 540 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N021292-001	EUTHYROX	0.025MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-002	EUTHYROX	0.05MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-003	EUTHYROX	0.075MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-004	EUTHYROX	0.088MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-005	EUTHYROX	0.1MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-006	EUTHYROX	0.112MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-007	EUTHYROX	0.125MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-008	EUTHYROX	0.137MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-009	EUTHYROX	0.15MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-010	EUTHYROX	0.175MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-011	EUTHYROX	0.2MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021292-012	EUTHYROX	0.3MG	TABLET / ORAL	2002-05-31	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N021292-001	EUTHYROX	0.025MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-002	EUTHYROX	0.05MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-003	EUTHYROX	0.075MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-004	EUTHYROX	0.088MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-005	EUTHYROX	0.1MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-006	EUTHYROX	0.112MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-007	EUTHYROX	0.125MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-008	EUTHYROX	0.137MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-009	EUTHYROX	0.15MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-010	EUTHYROX	0.175MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-011	EUTHYROX	0.2MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021292-012	EUTHYROX	0.3MG	TABLET / ORAL	2002-05-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021292-001	EUTHYROX	0.025MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-002	EUTHYROX	0.05MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-003	EUTHYROX	0.075MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-004	EUTHYROX	0.088MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-005	EUTHYROX	0.1MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-006	EUTHYROX	0.112MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-007	EUTHYROX	0.125MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-008	EUTHYROX	0.137MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-009	EUTHYROX	0.15MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-010	EUTHYROX	0.175MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-011	EUTHYROX	0.2MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021292-012	EUTHYROX	0.3MG	TABLET / ORAL	2002-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021292-001	EUTHYROX	0.025MG	TABLET / ORAL	2002-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021292-002	EUTHYROX	0.05MG	TABLET / ORAL	2002-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021292-003	EUTHYROX	0.075MG	TABLET / ORAL	2002-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021292-004	EUTHYROX	0.088MG	TABLET / ORAL	2002-05-31	`caaa826d4ba7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 11 · 440 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021292-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-006	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-007	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-008	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-009	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-010	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021292-011	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-006	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-007	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-008	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-009	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-010	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021292-011	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021292-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-006	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-007	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-008	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-009	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-010	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021292-011	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-006	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021292-007	AB2	1	`fd3edfee7708…`

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 11 of 14 · 265 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	ddec2148-f97e-4a79-9943-4bef2386a7f2	2025-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	7ade3f9e-e3d2-401b-a6b7-aa4c9d1c9861	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Direct_rx	2b4bbe49-4bd0-ba16-e063-6394a90acefc	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Direct_Rx	2b361866-e981-567c-e063-6294a90a5a5c	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	27e98e6d-9fd7-3a94-e063-6394a90a1dcb	2024-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	576dcd01-d151-42ac-acd1-480a13bae176	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	29bb8dbe-f8ba-e2ba-e063-6394a90af38c	2024-12-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	a0ffe111-3574-4481-a732-b68a7d58ef71	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	a55e735f-a5b0-4b85-9fd7-3a4b6723a81b	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	893f9d10-7ce5-4ae6-8f03-dfde35ca6c30	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	f23cacf6-0509-4e6b-bb59-6f1c17b16411	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	6edb9499-b869-4ec8-82d7-56d267fd3dec	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	2ee67e24-d72f-4419-a7d2-95bb44d9dd26	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	b57d0cc5-9fc7-496a-9bfa-417a288bb825	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	68a6702d-ca0b-4e04-88a6-4accc8fb459e	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	e1f77539-2156-4890-baca-8b13779c745c	2024-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals NY LLC	fca88c97-5cd4-4834-ba87-deb5bd637788	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	2646a481-09a5-af6a-e063-6394a90a16da	2024-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	924bb6e9-4b2b-406f-a0a8-376b1f22f1f5	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCarePharmaceuticals, Inc.	2380859a-5b65-f88f-e063-6394a90aa4e2	2024-10-02	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-025	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-050	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-075	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-088	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-100	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-112	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-125	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-137	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-150	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-175	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current
72305-200	EUTHYROX	levothyroxine sodium	Provell Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70915	SUPPL	2022-05-03
70873	SUPPL	2022-05-02
55504	SUPPL	2018-09-18
55503	SUPPL	2018-09-18
55502	SUPPL	2018-09-18
55498	SUPPL	2018-09-18
55497	SUPPL	2018-09-18
55496	SUPPL	2018-09-18
36600	SUPPL	2009-04-03
4947	SUPPL	2009-04-01
21579	ORIG	2004-06-29
15125	ORIG	2002-05-31
4946	ORIG	2002-05-31