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 3 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	Preferred Pharmaceuticals, Inc.	081b7bbb-6692-4512-b135-863b73bf30a5	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulate HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	825975b1-a4a9-78ca-e053-2a91aa0a3948	2025-09-02	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	QUAGEN PHARMACEUTICALS LLC	99a490cc-e41d-436b-9cf3-8facb7ac714f	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals, Inc.	99782bc8-56d9-41f8-935e-0d0de27f0c34	2025-05-19	Warnings, Adverse reactions	Name fallback brand name: Albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	1c72fd84-7dbc-45d0-ab88-fb4221ce369f	2025-05-16	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	264e2145-c7d4-4f4f-aa5b-9fe48a7c5b47	2025-05-07	Warnings, Adverse reactions	Name fallback brand name: Albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	a6545fbe-b0a6-41ae-8bb6-91af38410f56	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Chartwell RX, LLC	560df50c-e2c4-459f-9d89-bf7e6588949e	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	ecc00500-58b8-491f-80df-dc6c89a08cae	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	813d49be-3651-6759-e053-2991aa0a6a9f	2025-02-06	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	Lupin Pharmaceuticals, Inc.	973b8686-c6ce-4280-85c4-c1e7ceab3c09	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	52e209ac-7156-4496-ba5a-42ee59d45deb	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Albuterol sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	749992b4-69e0-0cc8-e053-2991aa0aeb25	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	9d4ef83f-8ca0-811e-e053-2995a90a6d0d	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Preferred Pharmaceuticals, Inc.	4aafc2dd-744d-4726-828f-70355aee6f70	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: ALBUTEROL SULFATE generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	53eecdef-a7ff-4ca3-a313-d4b9c29c898d	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Advanced Rx of Tennessee, LLC	04c8a345-0a0d-5a01-e063-6294a90a40d2	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Advanced Rx Pharmacy of Tennessee, LLC	f44b325d-0f74-552c-e053-2995a90ac1c9	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Albuterol Sulfate generic name: ALBUTEROL SULFATE
Albuterol Sulfate Inhalation	ALBUTEROL SULFATE	Amneal Pharmaceuticals NY LLC	2e449282-ee58-4e36-b983-85c4e6f0864d	2024-12-20	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Ingenus Pharmaceuticals, LLC	e14f5fd6-d01a-489d-9baa-61778b1352a8	2024-10-22	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