Application 077839

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 0.083% 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077839-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN		2008-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077839-001	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.

Product history page 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077839-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	AN	2008-12-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A077839-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077839-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077839-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077839-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077839-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077839-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077839-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077839-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077839-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077839-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077839-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077839-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077839-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077839-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077839-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077839-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077839-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077839-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077839-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077839-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077839-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077839-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077839-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077839-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077839-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077839-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077839-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077839-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077839-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077839-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077839-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077839-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077839-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077839-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077839-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077839-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077839-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077839-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077839-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077839-001	AN	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	4aec7f59-b429-4b0e-a779-8df1dd8f80d7	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839 ndc (product): 60687-395
Albuterol Sulfate	ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	b72742df-1a6b-4483-aff3-3e79db5e015d	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839 ndc (product): 76204-200
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	6ec88f64-66a2-4ca9-9913-c192fc33f88b	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	c90e80b2-882e-4c0c-bfac-d67eb1da724d	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	Mylan Pharmaceuticals Inc.	5329614f-ae0b-4854-bb6f-ea0b7dae87c0	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839 ndc (product): 0378-8270
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals, Inc.	2c3f975c-dbd8-0362-e063-6394a90a16dd	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839
Albuterol Sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	19867b61-77a2-46f1-97c7-7fadfec5882b	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839 ndc (product): 50090-0516
Albuterol Sulfate	ALBUTEROL SULFATE	Medical Purchasing Solutions, LLC	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077839 application number: ANDA077839 ndc (product): 71872-7054

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8270	Albuterol Sulfate	Albuterol Sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8270	Albuterol Sulfate	Albuterol Sulfate	Mylan Pharmaceuticals, Inc.	ANDA	Current
0591-3797	Albuterol Sulfate	Albuterol Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3797	Albuterol Sulfate	Albuterol Sulfate	Actavis Pharma, Inc.	ANDA	Current
0591-3797	Albuterol Sulfate	Albuterol Sulfate	Actavis Pharma, Inc.	ANDA	Current
0781-7155	Albuterol Sulfate	Albuterol Sulfate	Sandoz Inc.	ANDA	Current
33261-789	Albuterol Sulfate	Albuterol Sulfate	Aidarex Pharmaceuticals LLC	ANDA	Current
50090-0516	Albuterol Sulfate	Albuterol Sulfate	A-S Medication Solutions	ANDA	Current
50090-0516	Albuterol Sulfate	Albuterol Sulfate	A-S Medication Solutions	ANDA	Current
50090-0516	Albuterol Sulfate	Albuterol Sulfate	A-S Medication Solutions	ANDA	Current
50090-3400	Albuterol Sulfate	Albuterol Sulfate	A-S Medication Solutions	ANDA	Current
60687-395	Albuterol Sulfate	Albuterol Sulfate	American Health Packaging	ANDA	Current
60687-395	Albuterol Sulfate	Albuterol Sulfate	American Health Packaging	ANDA	Current
60687-395	Albuterol Sulfate	Albuterol Sulfate	American Health Packaging	ANDA	Current
65302-045	Albuterol Sulfate	Albuterol Sulfate	The Ritedose Corporation	ANDA	Current
68071-4199	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4226	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9298	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9298	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9298	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9298	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1095	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-1095	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-3442	Albuterol Sulfate	Albuterol Sulfate	REMEDYREPACK INC.	ANDA	Current
71872-7054	Albuterol Sulfate	Albuterol Sulfate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7054	Albuterol Sulfate	Albuterol Sulfate	Medical Purchasing Solutions, LLC	ANDA	Current
72189-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	Direct_Rx	ANDA	Current
72189-022	ALBUTEROL SULFATE	ALBUTEROL SULFATE	DIRECT RX	ANDA	Current
76204-200	Albuterol Sulfate	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-200	Albuterol Sulfate	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-200	Albuterol Sulfate	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-200	Albuterol Sulfate	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-200	Albuterol Sulfate	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-200	Albuterol Sulfate	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current
76204-200	Albuterol Sulfate	Albuterol Sulfate	Ritedose Pharmaceuticals, LLC	ANDA	Current