Application 021457

Type: NDA
Sponsor: TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROAIR HFA	ALBUTEROL SULFATE	AEROSOL, METERED;INHALATION	EQ 0.09MG BASE/INH	Yes	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
N021457-001	PROAIR HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021457-001	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.

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	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2004-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2004-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2004-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	2004-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021457-001	PROAIR HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB2	RLD, RS	2004-10-29	`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	N021457-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021457-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021457-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021457-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021457-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021457-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021457-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021457-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021457-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021457-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021457-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021457-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021457-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021457-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021457-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021457-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021457-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021457-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021457-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021457-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021457-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021457-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021457-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021457-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021457-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021457-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021457-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021457-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021457-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021457-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021457-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021457-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021457-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021457-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021457-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021457-001	AB2	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 339 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021457-001	10022509	2031-05-18	Drug product	2018-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021457-001	10022510	2031-05-18	Drug product	2018-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021457-001	10086156	2031-05-18	Drug product	2018-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021457-001	10695512	2031-05-18	Drug product	2020-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	8132712	2028-09-07	Drug product	2012-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	10022509	2031-05-18	Drug product	2018-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	10022510	2031-05-18	Drug product	2018-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	10086156	2031-05-18	Drug product	2018-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	10695512	2031-05-18	Drug product	2020-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	11395889	2031-05-18	Drug product	2022-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	9463289	2031-05-18	Drug product	2016-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	9808587	2031-05-18	Drug product	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021457-001	10561808	2032-01-01	Drug product	2020-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	8132712	2028-09-07	Drug product	2012-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	10022509	2031-05-18	Drug product	2018-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	10022510	2031-05-18	Drug product	2018-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	10086156	2031-05-18	Drug product	2018-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	10695512	2031-05-18	Drug product	2020-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	11395889	2031-05-18	Drug product	2022-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	9463289	2031-05-18	Drug product	2016-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	9808587	2031-05-18	Drug product	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021457-001	10561808	2032-01-01	Drug product	2020-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	8132712	2028-09-07	Drug product	2012-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	10022509	2031-05-18	Drug product	2018-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	10022510	2031-05-18	Drug product	2018-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	10086156	2031-05-18	Drug product	2018-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	10695512	2031-05-18	Drug product	2020-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	11395889	2031-05-18	Drug product	2022-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	9463289	2031-05-18	Drug product	2016-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	9808587	2031-05-18	Drug product	2017-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021457-001	10561808	2032-01-01	Drug product	2020-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	8132712	2028-09-07	Drug product	2012-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	10022509	2031-05-18	Drug product	2018-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	10022510	2031-05-18	Drug product	2018-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	10086156	2031-05-18	Drug product	2018-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	10695512	2031-05-18	Drug product	2020-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	11395889	2031-05-18	Drug product	2022-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	9463289	2031-05-18	Drug product	2016-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	9808587	2031-05-18	Drug product	2017-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021457-001	10561808	2032-01-01	Drug product	2020-03-19	`2680178bc6a6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol Sulfate HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	8c278b6f-d32b-b750-e053-2995a90ad7e9	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021457 application number: NDA021457 ndc (product): 68071-4940
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Asclemed USA, Inc.	a69489f7-4ffb-4cd1-b2d2-002f48e84f51	2023-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021457 application number: NDA021457 ndc (product): 76420-088
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Proficient Rx LP	d617e361-5c03-45ac-9bbe-0fa418edb19f	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021457 application number: NDA021457 ndc (product): 71205-211
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Teva Pharmaceuticals USA, Inc.	7bb5b6dd-9105-4ee7-b205-ed79cf4b371b	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021457 application number: NDA021457 ndc (product): 0093-3174

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3174	Albuterol Sulfate	Albuterol Sulfate	Teva Pharmaceuticals USA, Inc.	NDA	Current
0093-3174	Albuterol Sulfate	Albuterol Sulfate	Teva Pharmaceuticals USA, Inc.	NDA	Current
0093-3174	Albuterol Sulfate	Albuterol Sulfate	Teva Pharmaceuticals USA, Inc.	NDA	Current
0093-3174	Albuterol Sulfate	Albuterol Sulfate	Teva Pharmaceuticals USA, Inc.	NDA	Current
0093-3174	Albuterol Sulfate	Albuterol Sulfate	Teva Pharmaceuticals USA, Inc.	NDA	Current
0093-3174	Albuterol Sulfate	Albuterol Sulfate	Teva Pharmaceuticals USA, Inc.	NDA	Current
21695-851	PROAIR	albuterol sulfate	Rebel Distributors Corp	NDA	Current
49999-908	PROAIR	albuterol sulfate	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
49999-908	PROAIR	albuterol sulfate	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
50090-1329	PROAIR	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
50090-1329	PROAIR	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
50090-1329	PROAIR	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
50090-4138	Albuterol Sulfate	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
50090-4138	Albuterol Sulfate	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
50090-4138	Albuterol Sulfate	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
50090-4491	PROAIR	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
50090-4491	PROAIR	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
51662-1202	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1202	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1202	ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52959-978	PROAIRHFA	albuterol sulfate	H.J. Harkins Company, Inc.	NDA	Current
53002-1550	PROAIR	Albuterol Sulfate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1550	PROAIR	Albuterol Sulfate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1551	Albuterol Sulfate	Albuterol Sulfate	RPK Pharmaceuticals, Inc.	NDA	Current
59310-579	PROAIR	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-579	PROAIR	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-579	PROAIR	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-579	PROAIR	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
63187-540	PROAIR	albuterol sulfate	Proficient Rx LP	NDA	Current
63187-540	PROAIR	albuterol sulfate	Proficient Rx LP	NDA	Current
64725-5790	PROAIR	albuterol sulfate	TYA Pharmaceuticals	NDA	Current
68071-1525	PROAIR	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1525	PROAIR	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1525	PROAIR	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-4940	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-4940	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-4940	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	NDA	Current
68788-7477	Albuterol Sulfate	Albuterol Sulfate	Preferred Relabeled By: Preferred Pharmaceuticals Inc.	NDA	Current
68788-7477	Albuterol Sulfate	Albuterol Sulfate	Preferred Relabeled By: Preferred Pharmaceuticals Inc.	NDA	Current
68788-9900	PROAIR	albuterol sulfate	Preferred Pharmaceuticals, Inc	NDA	Current
68788-9900	PROAIR	albuterol sulfate	Preferred Pharmaceuticals, Inc	NDA	Current
68788-9900	PROAIR	albuterol sulfate	Preferred Pharmaceuticals, Inc	NDA	Current
70518-1230	PROAIR	Albuterol Sulfate	REMEDYREPACK INC.	NDA	Current
70518-1230	PROAIR	Albuterol Sulfate	REMEDYREPACK INC.	NDA	Current
70518-1230	PROAIR	Albuterol Sulfate	REMEDYREPACK INC.	NDA	Current
70518-1230	PROAIR	Albuterol Sulfate	REMEDYREPACK INC.	NDA	Current
71205-211	Albuterol Sulfate	Albuterol Sulfate	Proficient Rx LP	NDA	Current
71205-211	Albuterol Sulfate	Albuterol Sulfate	Proficient Rx LP	NDA	Current
71205-211	Albuterol Sulfate	Albuterol Sulfate	Proficient Rx LP	NDA	Current
71205-211	Albuterol Sulfate	Albuterol Sulfate	Proficient Rx LP	NDA	Current
76420-088	Albuterol Sulfate	Albuterol Sulfate	Asclemed USA, Inc.	NDA	Current
76420-088	Albuterol Sulfate	Albuterol Sulfate	Asclemed USA, Inc.	NDA	Current
76519-1171	ALBUTEROL SULFATE	ALBUTEROL SULFATE	H.J. Harkins Company, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57812	SUPPL	2019-02-26
57810	SUPPL	2019-02-26
15525	SUPPL	2012-11-29
27849	SUPPL	2010-12-15
5446	SUPPL	2010-08-20
15524	SUPPL	2010-08-19
36990	SUPPL	2008-09-19
27848	SUPPL	2008-09-17
21672	ORIG	2007-04-30
36988	SUPPL	2007-01-17
23958	SUPPL	2006-02-08
36989	SUPPL	2005-11-30
36987	SUPPL	2005-11-30
27847	SUPPL	2005-11-30
5445	SUPPL	2005-11-30
36986	SUPPL	2005-05-04
5444	SUPPL	2005-05-04
36985	ORIG	2004-11-08
5443	ORIG	2004-11-08