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 4 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	caf7825d-f434-472f-94f3-217a41255562	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	55cebc88-0514-4940-b974-ec7f0467d10e	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	c7d5b71b-e983-4b1a-bfc2-d2343cf8668c	2026-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	0235176b-ec39-44c4-a9e1-e0729a7989fa	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	7d07e932-7372-4c17-aa53-55087107fa52	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	73c3d459-dcbf-4458-8edd-2637275a96a1	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	2ecaa38f-8a6f-4536-8033-251d2c52ae64	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	4461bc9f-35db-4211-82ab-7671cf4dc14b	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	66bb0ba9-cd63-4817-907f-7b8ad5dc6685	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Tirosint SOL	LEVOTHYROXINE SODIUM	IBSA Pharma Inc.	5d378add-f13d-40f2-99dc-0f2340ab44b7	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	a0fa8fa5-d3bd-4e52-9ec5-5fb84702826d	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	70853a82-ba3b-4663-9f78-6791ca72ba9f	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	8ac112c3-1e06-4fdb-a7af-2ee988de5b15	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	69fb5cd6-90ba-487d-a754-07c664a1fdd1	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Tirosint	LEVOTHYROXINE SODIUM	IBSA Pharma Inc.	7a7ade79-0165-4e31-b84e-667416c00c7e	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	YARAL Pharma Inc.	d28d7202-1278-0486-e053-2995a90af286	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	7c8a6441-3c12-46ae-bb3b-a320d80045b6	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	008de8fd-150f-4022-8ccb-c8bfa94875c7	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	991399a4-ff94-44d0-b1ba-1f89e7759498	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	87333260-fe57-4d99-886c-7c66cb063898	2026-03-19	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