Application 209954

Type: ANDA
Sponsor: LUPIN ATLANTIS

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
A209954-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2		2020-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209954-001	AB2

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	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209954-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	2020-08-24	`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	A209954-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209954-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209954-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209954-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209954-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209954-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209954-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209954-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209954-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209954-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209954-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209954-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209954-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209954-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209954-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209954-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209954-001	AB2	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209954-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209954-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209954-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209954-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209954-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209954-001	AB2	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209954-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209954-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209954-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209954-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209954-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209954-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209954-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209954-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209954-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209954-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209954-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209954-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209954-001	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209954-001	AB2	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol sulfate	ALBUTEROL SULFATE	Sportpharm LLC	32d954ee-9790-4beb-95db-72dbf8efa639	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954
Albuterol sulfate	ALBUTEROL SULFATE	REMEDYREPACK INC.	0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954 ndc (product): 70518-3541
Albuterol sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals, Inc.	99782bc8-56d9-41f8-935e-0d0de27f0c34	2025-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954
Albuterol sulfate	ALBUTEROL SULFATE	Asclemed USA, Inc.	264e2145-c7d4-4f4f-aa5b-9fe48a7c5b47	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954
Albuterol sulfate	ALBUTEROL SULFATE	Lupin Pharmaceuticals, Inc.	973b8686-c6ce-4280-85c4-c1e7ceab3c09	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954 ndc (product): 68180-963
Albuterol sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	52e209ac-7156-4496-ba5a-42ee59d45deb	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954 ndc (product): 50090-5231
Albuterol Sulfate	ALBUTEROL SULFATE	Advanced Rx Pharmacy of Tennessee, LLC	f44b325d-0f74-552c-e053-2995a90ac1c9	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954
Albuterol sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	b478d9e9-9704-6af2-e053-2995a90aafd4	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954 ndc (product): 68071-2300
Albuterol sulfate	ALBUTEROL SULFATE	Proficient Rx LP	4100bce5-096c-42e4-9e4e-d11a0ab597d5	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209954 application number: ANDA209954 ndc (product): 71205-732

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5231	Albuterol sulfate	Albuterol sulfate	A-S Medication Solutions	ANDA	Current
50090-5231	Albuterol sulfate	Albuterol sulfate	A-S Medication Solutions	ANDA	Current
53002-1554	Albuterol sulfate	Albuterol sulfate	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-2300	Albuterol sulfate	Albuterol sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2300	Albuterol sulfate	Albuterol sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-963	Albuterol sulfate	Albuterol sulfate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-963	Albuterol sulfate	Albuterol sulfate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-963	Albuterol sulfate	Albuterol sulfate	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-3541	Albuterol sulfate	Albuterol sulfate	REMEDYREPACK INC.	ANDA	Current
71205-732	Albuterol sulfate	Albuterol sulfate	Proficient Rx LP	ANDA	Current