Application 214531

Type: ANDA
Sponsor: RITEDOSE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	SOLUTION;INHALATION	EQ 0.021% BASE	No	No
002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	SOLUTION;INHALATION	EQ 0.042% BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214531-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28
A214531-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214531-001	AN
A214531-002	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.

Product history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2021-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN		2021-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214531-001	ALBUTEROL SULFATE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RS	2021-12-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214531-002	ALBUTEROL SULFATE	EQ 0.042% BASE	SOLUTION / INHALATION	AN		2021-12-28	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A214531-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214531-002	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214531-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214531-002	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214531-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214531-002	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214531-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214531-002	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214531-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214531-002	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214531-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214531-002	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214531-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214531-002	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214531-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214531-002	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214531-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214531-002	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214531-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214531-002	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214531-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214531-002	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214531-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214531-002	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214531-001	AN	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214531-002	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214531-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214531-002	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214531-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214531-002	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214531-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214531-002	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214531-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214531-002	AN	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214531-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214531-002	AN	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214531-001	AN	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214531-002	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214531-001	AN	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214531-002	AN	1	`1c564ffb4f44…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate Inhalation Solution	ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	d4c532be-1f41-60d3-e053-2995a90a98be	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214531 application number: ANDA214531 ndc (product): 76204-011 ndc (product): 76204-010
Albuterol	ALBUTEROL	Mylan Pharmaceuticals Inc.	9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6	2026-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214531 application number: ANDA214531 ndc (product): 0378-7058 ndc (product): 0378-7057

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7057	Albuterol Sulfate	Albuterol Sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7057	Albuterol Sulfate	Albuterol Sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7058	Albuterol Sulfate	Albuterol Sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7058	Albuterol Sulfate	Albuterol Sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
65302-060	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	The Ritedose Corporation	ANDA	Current
65302-061	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	The Ritedose Corporation	ANDA	Current
65302-064	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	The Ritedose Corporation	ANDA	Current
65302-065	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	The Ritedose Corporation	ANDA	Current
76204-010	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-010	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-010	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-011	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-011	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-011	Albuterol Sulfate Inhalation Solution	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current