Application 078092

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, EXTENDED RELEASE;ORAL	EQ 8MG BASE	No	Yes
002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG 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
A078092-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29
A078092-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29

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	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL			2007-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078092-001	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2007-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078092-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2007-01-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078092-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078092-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078092-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078092-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078092-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078092-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078092-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078092-002	AB	1	`ea99ee380514…`

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 4 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	Padagis Israel Pharmaceuticals Ltd	489201d2-9ed0-419b-81dc-a7f7f86b59ed	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: albuterol sulfate generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Bryant Ranch Prepack	45e07bdd-78f9-4055-9de3-646e67de7eaf	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.	1d6be2b8-c670-b783-e063-6294a90ae503	2024-07-31	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Aurobindo Pharma Limited	78e6bee2-7113-46cf-8c97-dc61b0f7b94f	2024-07-31	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	b0f73459-baeb-42a7-be48-2c3647d9b205	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	b478d9e9-9704-6af2-e053-2995a90aafd4	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Albuterol sulfate generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	7043bc12-8a58-8ff8-e053-2a91aa0ab627	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	54d90668-5237-4330-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	8c278b6f-d32b-b750-e053-2995a90ad7e9	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	A-S Medication Solutions	aa6d5c00-46a5-4f93-95e4-09319abfe71e	2024-05-07	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	19867b61-77a2-46f1-97c7-7fadfec5882b	2024-05-07	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	A-S Medication Solutions	aff836e4-34f2-4ab9-bbf8-0c41ac848cb0	2024-05-07	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Prasco Laboratories	b25d9d6b-eb4c-452e-89ef-10e611deebd6	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	GlaxoSmithKline LLC	d92c5d6b-ff10-4087-36a2-1cfc464cb967	2024-04-26	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	767a1504-1e04-1e06-e053-2a91aa0aa4b6	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC.	7f261a9b-65d9-408a-8609-c1b3809b8b4b	2024-02-21	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC	4e48ccbe-3ec0-4bf2-be28-83eb9baa63d6	2024-02-21	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC	922bf33b-4d55-4c35-9f68-72efbb17c14f	2024-02-21	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	A-S Medication Solutions	7ad17b39-d2de-4108-abbf-cedd650c8edd	2024-02-18	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Asclemed USA, Inc.	a69489f7-4ffb-4cd1-b2d2-002f48e84f51	2023-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4122	Albuterol Sulfate	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4122	Albuterol Sulfate	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4124	Albuterol Sulfate	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4124	Albuterol Sulfate	albuterol sulfate	Mylan Pharmaceuticals Inc.	ANDA	Current