Application 074454

Type: ANDA
Sponsor: COSETTE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	SYRUP;ORAL	EQ 2MG BASE/5ML	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
A074454-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL			1995-09-25

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	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL		1995-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL		1995-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL		1995-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL		1995-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL		1995-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074454-001	ALBUTEROL SULFATE	EQ 2MG BASE/5ML	SYRUP / ORAL	AA	1995-09-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074454-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074454-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074454-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074454-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074454-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074454-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074454-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074454-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074454-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074454-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074454-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074454-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074454-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074454-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074454-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074454-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074454-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074454-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074454-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074454-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074454-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074454-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074454-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074454-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074454-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074454-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074454-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074454-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074454-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074454-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074454-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074454-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074454-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074454-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074454-001	AA	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 6 · 105 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	Rising Pharma Holdings, Inc.	3236f82c-14e9-dfd4-e063-6294a90ac43d	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Rising Pharma Holdings, Inc.	32377c09-da6d-331c-e063-6294a90a7a46	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Rising Pharma Holdings, Inc	32474c0e-af35-69d1-e063-6394a90a53c6	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	HAWAII REPACK, INC.	b18fad6e-f117-4840-83b7-8c261c646af1	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	4aec7f59-b429-4b0e-a779-8df1dd8f80d7	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	REMEDYREPACK INC.	0f9bf2c8-55c0-4b4d-97de-d6c7220c3862	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Cipla USA Inc.	c4d6d76a-14b8-411a-8019-e2c923c2c532	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	b0a5da99-6553-4088-ae27-7fa194438340	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate Inhalation Solution, 0.5%	ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	fdb4ac5a-bf0d-4896-89f7-1828c081b79e	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate Inhalation Solution	ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	d4c532be-1f41-60d3-e053-2995a90a98be	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Ritedose Pharmaceuticals, LLC	b72742df-1a6b-4483-aff3-3e79db5e015d	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
albuterol sulfate	ALBUTEROL SULFATE	Sportpharm LLC	440a96bb-9e69-bdcc-e063-6294a90a6793	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Sportpharm LLC	a33e20e0-3936-450d-a9d9-3ff51c6f26c5	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Sportpharm LLC	e31d8d13-ac19-4738-97d4-d7790ce2e8e3	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	Sportpharm LLC	32d954ee-9790-4beb-95db-72dbf8efa639	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
albuterol sulfate	ALBUTEROL SULFATE	Golden State Medical Supply, Inc.	a22af54a-c010-ab8b-e053-2a95a90a8862	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	REMEDYREPACK INC.	0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Sun Pharmaceutical Industries, Inc.	bb538b7d-e390-419a-9404-a57c1db4a447	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Cardinal Health 107, LLC	6ec88f64-66a2-4ca9-9913-c192fc33f88b	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0472-0825	Albuterol Sulfate	Albuterol Sulfate	Actavis Pharma, Inc.	ANDA	Current
0472-0825	Albuterol Sulfate	Albuterol Sulfate	Actavis Pharma, Inc.	ANDA	Current
0472-0825	Albuterol Sulfate	Albuterol Sulfate	Actavis Pharma, Inc.	ANDA	Current
0472-0825	Albuterol Sulfate	Albuterol Sulfate	Actavis Pharma, Inc.	ANDA	Current
67296-1348	Albuterol Sulfate	Albuterol Sulfate	RedPharm Drug, Inc.	ANDA	Current
67296-1348	Albuterol Sulfate	Albuterol Sulfate	RedPharm Drug, Inc.	ANDA	Current
68788-7390	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7390	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current