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 3 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	231fcdf8-c642-4074-8be8-53ee9c918f18	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	251e65e0-6925-4984-9df9-d6d7c6d0703c	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	3142571d-f253-45e7-adc1-6ca80d34cab1	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	513d066a-2fcc-44ad-80e1-23c339a56ac6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	741a8b30-86e1-4f37-917a-73265a82ee07	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	1aaa327d-bb10-4815-8bd3-d8c9edc6c9db	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	64a663ac-ac02-4325-8f21-ee212e546121	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	51b68266-95d2-c166-e063-6294a90a534f	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	50fe00b3-6610-1cac-e063-6294a90af8ac	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	5100c561-0028-a3c0-e063-6394a90addeb	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	510349d0-6397-7e2b-e063-6394a90a8a68	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	f94a81e2-49cd-430a-acda-1a47d5c5b59b	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	4a2c8e57-d52d-409f-83d8-731b721bf613	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	4caf9040-5507-45a4-8f42-231aa925ab8d	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	f347d92a-7726-4165-bc3c-f5b37ec86f9f	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	f8c14539-8ed1-406a-9b58-8ba3a7ce7ee3	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	0210a600-747e-433a-8ba9-11692ecfb54a	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	ef7bc627-d37b-470e-b8f7-3c472c930d05	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d0beda93-9454-4846-b5c6-2a9113fb1765	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	0b9d21d8-9b49-4fd2-b516-b25bc6a6b671	2026-04-07	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