Application 020983

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENTOLIN HFA	ALBUTEROL SULFATE	AEROSOL, METERED;INHALATION	EQ 0.09MG BASE/INH	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020983-001	VENTOLIN HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB3	RLD, RS	2001-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020983-001	AB3

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 · 44 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
2026-10-15 13:18:30	2026-09	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB3	RLD, RS	2001-04-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB3	RLD, RS	2001-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB3	RLD, RS	2001-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020983-001	VENTOLIN HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2001-04-19	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020983-001	AB3	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020983-001	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020983-001	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020983-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020983-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020983-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020983-001	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020983-001	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020983-001	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020983-001	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020983-001	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020983-001	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020983-001	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020983-001	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020983-001	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020983-001	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020983-001	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020983-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020983-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020983-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020983-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020983-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020983-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020983-001	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020983-001	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020983-001	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020983-001	BX	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020983-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020983-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020983-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020983-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020983-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020983-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020983-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020983-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020983-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020983-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020983-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020983-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020983-001	BX	1	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 2 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020983-001	7500444	2026-02-26	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020983-001	7500444*PED	2026-08-26	Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020983-001	7350676*PED	2019-02-24	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020983-001	9861771	2020-10-11	Drug product	2018-03-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020983-001	7500444	2026-02-26	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020983-001	7500444*PED	2026-08-26	Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020983-001	7350676*PED	2019-02-24	Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020983-001	9861771	2020-10-11	Drug product	2018-03-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020983-001	7500444	2026-02-26	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020983-001	7500444*PED	2026-08-26	Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020983-001	7350676*PED	2019-02-24	Pediatric extension		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020983-001	9861771	2020-10-11	Drug product	2018-03-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020983-001	7500444	2026-02-26	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020983-001	7500444*PED	2026-08-26	Pediatric extension		`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020983-001	7500444	2026-02-26	Drug product		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020983-001	7500444*PED	2026-08-26	Pediatric extension		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020983-001	7500444	2026-02-26	Drug product		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020983-001	7500444*PED	2026-08-26	Pediatric extension		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020983-001	7500444	2026-02-26	Drug product		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020983-001	7500444*PED	2026-08-26	Pediatric extension		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020983-001	7500444	2026-02-26	Drug product		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020983-001	7500444*PED	2026-08-26	Pediatric extension		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020983-001	7832351	2023-06-19	Drug product	2012-09-07	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020983-001	7832351*PED	2023-12-19	Pediatric extension		`3f0d92c62455…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulate HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	77d34a3c-ccc6-420a-ad31-a1af55f7de76	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 70518-2072
VENTOLIN HFA	ALBUTEROL SULFATE	REMEDYREPACK INC.	2ed73618-be3a-4331-9509-6401258f791f	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 70518-1237
Albuterol Sulate HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	825975b1-a4a9-78ca-e053-2a91aa0a3948	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 68071-4777
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Advanced Rx of Tennessee, LLC	04c8a345-0a0d-5a01-e063-6294a90a40d2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983
VENTOLIN HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	7043bc12-8a58-8ff8-e053-2a91aa0ab627	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 68071-1890
VENTOLIN HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	54d90668-5237-4330-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 68071-1670
VENTOLIN HFA	ALBUTEROL SULFATE	A-S Medication Solutions	aa6d5c00-46a5-4f93-95e4-09319abfe71e	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 50090-1158
VENTOLIN HFA	ALBUTEROL SULFATE	A-S Medication Solutions	aff836e4-34f2-4ab9-bbf8-0c41ac848cb0	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 50090-1159
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Prasco Laboratories	b25d9d6b-eb4c-452e-89ef-10e611deebd6	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 66993-019
VENTOLIN HFA	ALBUTEROL SULFATE	GlaxoSmithKline LLC	d92c5d6b-ff10-4087-36a2-1cfc464cb967	2024-04-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 0173-0682
ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	767a1504-1e04-1e06-e053-2a91aa0aa4b6	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 51662-1267
VENTOLIN HFA	ALBUTEROL SULFATE	Proficient Rx LP	6dc143e7-6bab-42c8-b3e9-9d604d202e73	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 63187-026
albuterol sulfate HFA	ALBUTEROL SULFATE	A-S Medication Solutions	4378c5b0-529f-44b4-bdf1-e9f2631df8cd	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020983 application number: NDA020983 ndc (product): 50090-4137

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 75 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0682	VENTOLIN	albuterol sulfate	GlaxoSmithKline LLC	NDA	Current
0173-0682	VENTOLIN	albuterol sulfate	GlaxoSmithKline LLC	NDA	Current
0173-0682	VENTOLIN	albuterol sulfate	GlaxoSmithKline LLC	NDA	Current
0173-0682	VENTOLIN	albuterol sulfate	GlaxoSmithKline LLC	NDA	Current
0173-0682	VENTOLIN	albuterol sulfate	GlaxoSmithKline LLC	NDA	Current
0173-0682	VENTOLIN	albuterol sulfate	GlaxoSmithKline LLC	NDA	Current
0173-0682	VENTOLIN	albuterol sulfate	GlaxoSmithKline LLC	NDA	Current
21695-423	VENTOLINHFA	albuterol sulfate	Rebel Distributors Corp.	NDA	Current
35356-166	VENTOLIN	albuterol sulfate	Lake Erie Medical DBA Qua	NDA	Current
35356-166	VENTOLIN	albuterol sulfate	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50090-1158	VENTOLIN	albuterol sulfate	A-S Medication Solutions	NDA	Current
50090-1159	VENTOLIN	albuterol sulfate	A-S Medication Solutions	NDA	Current
50090-1159	VENTOLIN	albuterol sulfate	A-S Medication Solutions	NDA	Current
50090-1159	VENTOLIN	albuterol sulfate	A-S Medication Solutions	NDA	Current
50090-4137	albuterol sulfate HFA	albuterol sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4137	albuterol sulfate HFA	albuterol sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4137	albuterol sulfate HFA	albuterol sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4137	albuterol sulfate HFA	albuterol sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4143	Albuterol Sulfate	albuterol sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4143	Albuterol Sulfate	albuterol sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50436-0682	VENTOLIN	albuterol sulfate	Unit Dose Services	NDA	Current
50436-6050	VENTOLIN	albuterol sulfate	Unit Dose Services	NDA	Current
51662-1267	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1267	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1267	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1267	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52959-983	VENTOLIN	albuterol sulfate	H.J. Harkins Company, Inc.	NDA	Current
53002-1584	VENTOLIN	albuterol sulfate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1584	VENTOLIN	albuterol sulfate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-2584	Albuterol Sulfate	albuterol sulfate	RPK Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
63187-026	VENTOLIN	albuterol sulfate	Proficient Rx LP	NDA	Current
63187-026	VENTOLIN	albuterol sulfate	Proficient Rx LP	NDA	Current
63187-026	VENTOLIN	albuterol sulfate	Proficient Rx LP	NDA	Current
63187-026	VENTOLIN	albuterol sulfate	Proficient Rx LP	NDA	Current
66993-019	Albuterol Sulfate	albuterol sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-019	Albuterol Sulfate	albuterol sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-019	Albuterol Sulfate	albuterol sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-019	Albuterol Sulfate	albuterol sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-019	Albuterol Sulate	albuterol sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-019	Albuterol Sulfate	albuterol sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-019	Albuterol Sulfate	albuterol sulfate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
68071-1670	VENTOLIN	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1670	VENTOLIN	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1670	VENTOLIN	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1890	VENTOLIN	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1890	VENTOLIN	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1890	VENTOLIN	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1890	VENTOLIN	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-4777	Albuterol Sulate	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4777	Albuterol Sulate	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4777	Albuterol Sulate	albuterol sulfate	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68258-3037	VENTOLIN	albuterol sulfate	Dispensing Solutions Inc.	NDA	Current
68788-7229	VENTOLIN	albuterol sulfate	Preferred Pharmaceuticals Inc.	NDA	Current
68788-7229	VENTOLIN	albuterol sulfate	Preferred Pharmaceuticals Inc.	NDA	Current
68788-7353	Albuterol Sulate	albuterol sulfate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7353	Albuterol Sulate	albuterol sulfate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7353	Albuterol Sulate	albuterol sulfate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7353	Albuterol Sulate	albuterol sulfate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-9552	VENTOLIN	albuterol sulfate	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-9552	VENTOLIN	albuterol sulfate	Preferred Pharmaceuticals, Inc.	NDA	Current
70518-1081	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1081	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1081	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1081	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1237	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1237	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1237	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1237	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1237	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1237	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-1237	VENTOLIN	albuterol sulfate	REMEDYREPACK INC.	NDA	Current
70518-2072	Albuterol Sulate	albuterol sulfate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2072	Albuterol Sulate	albuterol sulfate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
72189-016	VENTOLIN HFA	albuterol sulfate	DIRECT RX	NDA	Current
76519-1175	ALBUTEROL SULFATE	ALBUTEROL SULFATE	H.J. Harkins Company, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68421	SUPPL	2021-08-19
68413	SUPPL	2021-08-19
61340	SUPPL	2019-12-19
61322	SUPPL	2019-12-17
14083	SUPPL	2015-01-09
3934	SUPPL	2014-12-23
35786	SUPPL	2012-09-11
3933	SUPPL	2012-09-07
41860	SUPPL	2012-02-14
51192	SUPPL	2008-08-27
51189	SUPPL	2008-08-27
51185	SUPPL	2008-08-27
51157	SUPPL	2008-08-27
51155	SUPPL	2008-08-27
26373	SUPPL	2008-04-02
14082	SUPPL	2008-03-27
35785	SUPPL	2005-04-28
3932	SUPPL	2005-04-28
35784	ORIG	2001-04-19
21326	ORIG	2001-04-19
3931	ORIG	2001-04-19
53162	SUPPL	1900-01-01
53161	SUPPL	1900-01-01
53160	SUPPL	1900-01-01