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 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
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 · 82 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	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…`
2022-03-09 01:35 UTC	2022-03	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072894-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	RS	1991-01-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072894-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1991-01-17	`782e0a99824c…`

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 2 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	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
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	285a656c-f77f-4e77-b0a8-a0e9c901803f	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
albuterol sulfate	ALBUTEROL SULFATE	Sun Pharmaceutical Industries, Inc.	87b8cd3c-2849-4b50-b63e-9ea379165c07	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	c90e80b2-882e-4c0c-bfac-d67eb1da724d	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Mylan Pharmaceuticals Inc.	5329614f-ae0b-4854-bb6f-ea0b7dae87c0	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulate HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	77d34a3c-ccc6-420a-ad31-a1af55f7de76	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	1f0bf143-66d4-4a39-b2d1-a5c460ffdcf9	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	2ed73618-be3a-4331-9509-6401258f791f	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	5de6a189-a8b7-4b33-b162-add6b6e4b275	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	adb8d669-b91c-46f1-8a86-19f504840eff	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	d6acb5a7-555a-463a-ae65-2911d6789b42	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol	ALBUTEROL SULFATE	Cipla USA Inc.	fd0389e0-3713-42e0-8ef2-3bb97676fded	2026-01-04	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Chartwell Governmental & Specialty RX, LLC.	dd47559a-84f6-42a5-a00e-48754505418e	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Sandoz Inc	f8a2c4b7-a162-48ab-90b0-350e4da25c66	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	REMEDYREPACK INC.	32dbec5e-044a-40b6-9b88-e1396c4b4b6e	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Bryant Ranch Prepack	378461f2-7271-44a3-9da3-b39970b65d3a	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	574824f3-51cc-4b94-9c10-e3204d8b19f8	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	ASCLEMED USA INC.	8ea40065-4f59-434f-9ea1-7ef006fde66e	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	056e145b-87aa-4009-a7ab-2ac0bd086eb0	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals, Inc.	2c3f975c-dbd8-0362-e063-6394a90a16dd	2025-10-21	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 · 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