Application 207085

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	AEROSOL, METERED;INHALATION	EQ 0.09MG BASE/INH	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
A207085-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1		2021-06-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207085-001	AB1

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.

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	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207085-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2021-06-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207085-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207085-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207085-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207085-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207085-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207085-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207085-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207085-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207085-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207085-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207085-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207085-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207085-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207085-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207085-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207085-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207085-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207085-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207085-001	AB1	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207085-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207085-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207085-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207085-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207085-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207085-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207085-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207085-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207085-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207085-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207085-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207085-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207085-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207085-001	AB1	1	`a50c72e98297…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	HAWAII REPACK, INC.	b18fad6e-f117-4840-83b7-8c261c646af1	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207085 application number: ANDA207085
Albuterol Sulfate	ALBUTEROL SULFATE	Sportpharm LLC	e31d8d13-ac19-4738-97d4-d7790ce2e8e3	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207085 application number: ANDA207085
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	1f0bf143-66d4-4a39-b2d1-a5c460ffdcf9	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207085 application number: ANDA207085
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	53eecdef-a7ff-4ca3-a313-d4b9c29c898d	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207085 application number: ANDA207085
Albuterol Sulfate	ALBUTEROL SULFATE	Hikma Pharmaceuticals USA Inc.	6c64ab5d-f8a2-440a-a929-cb8188d0e8b4	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207085 application number: ANDA207085 ndc (product): 0054-0742
Albuterol Sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	87ff8be7-3a49-44bd-92de-eb8db24af95b	2022-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207085 application number: ANDA207085 ndc (product): 76420-531

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0742	Albuterol Sulfate	Albuterol Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0742	Albuterol Sulfate	Albuterol Sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
76420-531	Albuterol Sulfate	Albuterol Sulfate	Asclemed USA, Inc.	ANDA	Current