Application 072894

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	TABLET;ORAL	EQ 4MG BASE	No	Yes
002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	TABLET;ORAL	EQ 2MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A072894-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL			1991-01-17
A072894-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL			1991-01-17

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL			1991-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL			1991-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL			1991-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL			1991-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A072894-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072894-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072894-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072894-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072894-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072894-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072894-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072894-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072894-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072894-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072894-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072894-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072894-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072894-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072894-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072894-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072894-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072894-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072894-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072894-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072894-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072894-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072894-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072894-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072894-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072894-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072894-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072894-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072894-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072894-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072894-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072894-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072894-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072894-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072894-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072894-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072894-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072894-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072894-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072894-002	AB	1	`782e0a99824c…`

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 5 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Proficient Rx LP	d617e361-5c03-45ac-9bbe-0fa418edb19f	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	Proficient Rx LP	6dc143e7-6bab-42c8-b3e9-9d604d202e73	2023-10-01	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	A-S Medication Solutions	a9188951-3711-412c-89c6-e8db784dcb65	2023-09-20	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	8f52f15f-3fb7-4b00-a19f-8721c5ac55db	2023-07-24	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC	81cdae6f-99d7-468b-9ab8-fecb1d42298d	2023-06-19	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Medical Purchasing Solutions, LLC	6a4b4b95-d1d3-9051-e053-2a91aa0a52e8	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
albuterol sulfate HFA	ALBUTEROL SULFATE	A-S Medication Solutions	4378c5b0-529f-44b4-bdf1-e9f2631df8cd	2023-02-06	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Hikma Pharmaceuticals USA Inc.	6c64ab5d-f8a2-440a-a929-cb8188d0e8b4	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	Proficient Rx LP	4100bce5-096c-42e4-9e4e-d11a0ab597d5	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	87ff8be7-3a49-44bd-92de-eb8db24af95b	2022-12-13	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ad299502-8779-d280-e053-2995a90a7371	2022-12-10	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
albuterol sulfate	ALBUTEROL SULFATE	Proficient Rx LP	918551c7-c3c1-43bc-b575-b33fdb4e96fc	2022-12-01	Warnings, Adverse reactions	Name fallback brand name: albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Exelan Pharmaceuticals, Inc.	29e35e54-dbd6-4426-993f-893d7a4d69be	2022-02-10	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d	2020-10-16	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE

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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0255	Albuterol	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0255	Albuterol	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0255	Albuterol	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0255	Albuterol	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0572	Albuterol	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0572	Albuterol	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0572	Albuterol	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0572	Albuterol	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-657	Albuterol	albuterol	Mylan Institutional Inc.	ANDA	Current
51079-657	Albuterol	Albuterol	Mylan Institutional Inc.	ANDA	Current
51079-657	Albuterol	Albuterol	Mylan Institutional Inc.	ANDA	Current
51079-658	Albuterol	albuterol	Mylan Institutional Inc.	ANDA	Current
55289-045	Albuterol	albuterol sulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-045	Albuterol	albuterol sulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-045	Albuterol	albuterol sulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-045	Albuterol	albuterol sulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-045	Albuterol	albuterol sulfate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current