Application 075664

Type: ANDA
Sponsor: NEPHRON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	SOLUTION;INHALATION	EQ 0.5% BASE	No	Yes

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
A075664-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075664-001	AN

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 · 41 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	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN		2001-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN		2001-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN		2001-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN		2001-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075664-001	ALBUTEROL SULFATE	EQ 0.5% BASE	SOLUTION / INHALATION	AN	RS	2001-06-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A075664-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075664-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075664-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075664-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075664-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075664-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075664-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075664-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075664-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075664-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075664-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075664-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075664-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075664-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075664-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075664-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075664-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075664-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075664-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075664-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075664-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075664-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075664-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075664-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075664-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075664-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075664-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075664-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075664-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075664-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075664-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075664-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075664-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075664-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075664-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075664-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075664-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075664-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075664-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075664-001	AN	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate	ALBUTEROL SULFATE	Rising Pharma Holdings, Inc.	3236f82c-14e9-dfd4-e063-6294a90ac43d	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075664 application number: ANDA075664
Albuterol Sulfate	ALBUTEROL SULFATE	Nephron Pharmaceuticals Corporation	ecc00500-58b8-491f-80df-dc6c89a08cae	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075664 application number: ANDA075664 ndc (product): 0487-9901
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC.	7f261a9b-65d9-408a-8609-c1b3809b8b4b	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075664 application number: ANDA075664

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0487-9901	Albuterol Sulfate	Albuterol Sulfate	Nephron SC Inc.	ANDA	Current
0487-9901	Albuterol Sulfate	Albuterol Sulfate	Nephron Pharmaceuticals Corporation	ANDA	Current
55154-4350	Albuterol Sulfate	Albuterol Sulfate	Cardinal Health, Inc.	ANDA	Current
55154-4350	Albuterol Sulfate	Albuterol Sulfate	Cardinal Health 107, LLC	ANDA	Current
55154-4350	Albuterol Sulfate	Albuterol Sulfate	Cardinal Health, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43018	ORIG	2005-07-22
8754	ORIG	2003-04-14