Application 075129

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	SOLUTION;INHALATION	EQ 0.083% 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075129-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION			2001-02-13

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075129-001	ALBUTEROL SULFATE	EQ 0.083% BASE	SOLUTION / INHALATION	2001-02-13	`f41ea6bd6efb…`

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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30765	ORIG	2001-02-13