Application 215809

Type: NDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERMEZA	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	150MCG/5ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215809-001	ERMEZA	LEVOTHYROXINE SODIUM	150MCG/5ML	SOLUTION / ORAL		RLD	2022-04-29

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215809-001	9345772	2035-02-27		Drug product	2022-05-13

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD	2022-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215809-001	ERMEZA	150MCG/5ML	SOLUTION / ORAL	RLD, RS	2022-04-29	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215809-001	9345772	2035-02-27	Drug product	2022-05-13	`a50c72e98297…`

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 · 274 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49502-378	ERMEZA	levothyroxine sodium	Mylan Specialty L.P.	NDA	Current
49502-378	ERMEZA	levothyroxine sodium	Mylan Specialty L.P.	NDA	Current
49502-378	ERMEZA	levothyroxine sodium	Mylan Specialty L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72663	ORIG	2022-11-21
71978	ORIG	2022-08-31
70867	ORIG	2022-04-29