Application 215621

Type: ANDA
Sponsor: SLAYBACK PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	SOLUTION;INHALATION	0.02MG/2ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A215621-001	FORMOTEROL FUMARATE	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN		2022-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215621-001	AN

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215621-001	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	2022-12-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215621-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215621-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215621-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215621-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215621-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215621-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215621-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215621-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215621-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215621-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215621-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215621-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215621-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215621-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215621-001	AN	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215621-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215621-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215621-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215621-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215621-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215621-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215621-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215621-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215621-001	AN	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215621-001	AN	1	`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 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Formoterol fumarate	FORMOTEROL FUMARATE DIHYDRATE	NorthStar RxLLC	4dbb9620-5731-40d9-8258-2977ecc781c4	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Formoterol fumarate
Formoterol fumarate	FORMOTEROL FUMARATE DIHYDRATE	Lifestar Pharma LLC	35538d89-a984-4335-acdf-85a893f51eee	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Formoterol fumarate
Formoterol Fumarate	FORMOTEROL FUMARATE	Alembic Pharmaceuticals Inc.	07afdf7e-c480-4806-b469-a6a460522bc0	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Formoterol Fumarate generic name: FORMOTEROL FUMARATE
Formoterol Fumarate	FORMOTEROL FUMARATE	Ingenus Pharmaceuticals, LLC	303479a7-80fb-1f6d-e063-6394a90abbda	2025-06-05	Warnings, Adverse reactions	Name fallback brand name: Formoterol Fumarate generic name: FORMOTEROL FUMARATE
Formoterol fumarate	FORMOTEROL FUMARATE DIHYDRATE	Devatis, Inc.	fd0dac5d-e58c-46ee-9d28-1a1ef7a6be5e	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: Formoterol fumarate
Formoterol Fumarate	FORMOTEROL FUMARATE	Dr. Reddy's Laboratories Inc.	2010b5cb-c277-57dd-ed6b-607cad2c45a4	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Formoterol Fumarate generic name: FORMOTEROL FUMARATE
formoterol fumarate	FORMOTEROL FUMARATE	Lupin Pharmaceuticals, Inc.	44284e8c-0503-48c4-ae71-a0d6b865665d	2025-01-13	Warnings, Adverse reactions	Name fallback brand name: formoterol fumarate generic name: FORMOTEROL FUMARATE
Formoterol fumarate	FORMOTEROL FUMARATE	Micro Labs Limited	0796acea-70d6-479f-af48-18723b1efd2a	2024-09-26	Warnings, Adverse reactions	Name fallback brand name: Formoterol fumarate generic name: FORMOTEROL FUMARATE
Formoterol fumarate	FORMOTEROL FUMARATE	Bryant Ranch Prepack	d8f7c5ff-bd3c-4eab-b58a-1e3a478e5879	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Formoterol fumarate generic name: FORMOTEROL FUMARATE
Formoterol fumarate	FORMOTEROL FUMARATE	Bryant Ranch Prepack	9786f3e2-4265-4246-9999-f73cd6b33fc8	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Formoterol fumarate generic name: FORMOTEROL FUMARATE
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE DIHYDRATE	Mylan Pharmaceuticals Inc.	6c1a6c53-af85-4220-9ce3-2373e0928f7f	2020-12-15	Warnings, Adverse reactions	Name fallback brand name: FORMOTEROL FUMARATE
Formoterol fumarate	FORMOTEROL FUMARATE	Teva Pharmaceuticals USA, Inc.	419bc85d-8e24-478b-921e-babfb73e79f3	2020-10-31	Warnings, Adverse reactions	Name fallback brand name: Formoterol fumarate generic name: FORMOTEROL FUMARATE