Application 209959

Type: ANDA
Sponsor: CIPLA

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
A209959-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1		2020-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209959-001	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	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209959-001	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	2020-04-08	`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	A209959-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209959-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209959-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209959-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209959-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209959-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209959-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209959-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209959-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209959-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209959-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209959-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209959-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209959-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209959-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209959-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209959-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209959-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209959-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209959-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209959-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209959-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209959-001	AB1	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209959-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209959-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209959-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209959-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209959-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209959-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209959-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209959-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209959-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209959-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209959-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209959-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209959-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209959-001	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	Cipla USA Inc.	c4d6d76a-14b8-411a-8019-e2c923c2c532	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959 ndc (product): 69097-142
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	b0a5da99-6553-4088-ae27-7fa194438340	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959 ndc (product): 60687-662
Albuterol Sulfate	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	1c72fd84-7dbc-45d0-ab88-fb4221ce369f	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959
ALBUTEROL SULFATE	ALBUTEROL SULFATE	A-S Medication Solutions	7ad17b39-d2de-4108-abbf-cedd650c8edd	2024-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959
ALBUTEROL SULFATE	ALBUTEROL SULFATE	A-S Medication Solutions	a9188951-3711-412c-89c6-e8db784dcb65	2023-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959 ndc (product): 50090-5179
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Exelan Pharmaceuticals, Inc.	29e35e54-dbd6-4426-993f-893d7a4d69be	2022-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209959 application number: ANDA209959 ndc (product): 76282-679

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5179	ALBUTEROL SULFATE	albuterol sulfate	A-S Medication Solutions	ANDA	Current
50090-5179	ALBUTEROL SULFATE	albuterol sulfate	A-S Medication Solutions	ANDA	Current
60687-662	Albuterol Sulfate	Albuterol Sulfate	American Health Packaging	ANDA	Current
69097-142	ALBUTEROL SULFATE	albuterol sulfate	Cipla USA Inc.	ANDA	Current
69097-142	ALBUTEROL SULFATE	albuterol sulfate	Cipla USA Inc.	ANDA	Current
69097-142	ALBUTEROL SULFATE	albuterol sulfate	Cipla USA Inc.	ANDA	Current
69097-142	ALBUTEROL SULFATE	albuterol sulfate	Cipla USA Inc.	ANDA	Current
69097-142	ALBUTEROL SULFATE	albuterol sulfate	Cipla USA Inc.	ANDA	Current
69097-142	ALBUTEROL SULFATE	albuterol sulfate	Cipla USA Inc.	ANDA	Current
69097-142	ALBUTEROL SULFATE	albuterol sulfate	Cipla USA Inc.	ANDA	Current
69097-142	ALBUTEROL SULFATE	albuterol sulfate	Cipla USA Inc.	ANDA	Current
72572-014	ALBUTEROL SULFATE	albuterol sulfate	Civica Inc.	ANDA	Current
72572-014	ALBUTEROL SULFATE	albuterol sulfate	Civica Inc.	ANDA	Current
72572-014	ALBUTEROL SULFATE	albuterol sulfate	Civica Inc.	ANDA	Current
72572-014	ALBUTEROL SULFATE	albuterol sulfate	Civica Inc.	ANDA	Current
72572-014	ALBUTEROL SULFATE	albuterol sulfate	Civica Inc.	ANDA	Current
76282-679	ALBUTEROL SULFATE	albuterol sulfate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-679	ALBUTEROL SULFATE	albuterol sulfate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-679	ALBUTEROL SULFATE	albuterol sulfate	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-679	ALBUTEROL SULFATE	albuterol sulfate	Exelan Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62990	ORIG	2020-05-14