Application 205636

Type: NDA
Sponsor: TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROAIR RESPICLICK	ALBUTEROL SULFATE	POWDER, METERED;INHALATION	EQ 0.09MG BASE/INH	Yes	Yes
002	PROAIR DIGIHALER	ALBUTEROL SULFATE	POWDER, METERED;INHALATION	EQ 0.09MG BASE/INH	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205636-001	PROAIR RESPICLICK	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION		RLD, RS	2015-03-31
N205636-002	PROAIR DIGIHALER	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION		RLD	2018-12-21

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,149 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	N205636-001	10765820	2025-05-19	Drug product	2020-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	9463288	2025-05-19	Drug product	2016-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	8651103	2028-03-26	Drug product	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	10022510	2031-05-18	Drug product	2018-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	10124131	2031-05-18	Drug product	2018-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	9731087	2031-05-18	Drug product	2017-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	9216260	2031-06-28	Drug product	2016-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-001	8978966	2032-01-13	Drug product	2016-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10765820	2025-05-19	Drug product	2020-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9463288	2025-05-19	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	8651103	2028-03-26	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10022510	2031-05-18	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10124131	2031-05-18	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9731087	2031-05-18	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9216260	2031-06-28	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	8978966	2032-01-13	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9782550	2035-08-28	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	9782551	2035-08-28	Drug product	2019-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10918816	2035-12-14	Drug product	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	10569034	2036-08-16	Drug product	2020-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11351317	2038-02-10	Drug product	2022-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11357935	2038-09-24	Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11000653	2038-12-18	Drug product	2021-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11344685	2039-09-26	Drug product	2022-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11439777	2040-05-24	Drug product	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11464923	2040-06-19	Drug product	2022-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11173259	2040-07-06	Drug product	2021-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205636-002	11266796	2041-02-22	Drug product	2022-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	10765820	2025-05-19	Drug product	2020-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	9463288	2025-05-19	Drug product	2016-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	8651103	2028-03-26	Drug product	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	10022510	2031-05-18	Drug product	2018-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	10124131	2031-05-18	Drug product	2018-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	9731087	2031-05-18	Drug product	2017-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	9216260	2031-06-28	Drug product	2016-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	10561808	2032-01-01	Drug product	2020-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-001	8978966	2032-01-13	Drug product	2016-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-002	10765820	2025-05-19	Drug product	2020-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-002	9463288	2025-05-19	Drug product	2019-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205636-002	8651103	2028-03-26	Drug product	2019-01-09	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205636-001	NPP	2019-04-28	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N205636-001	NPP	2019-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205636-001	NPP	2019-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205636-001	NPP	2019-04-28	`ea99ee380514…`

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 4 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
albuterol sulfate	ALBUTEROL SULFATE	Padagis Israel Pharmaceuticals Ltd	489201d2-9ed0-419b-81dc-a7f7f86b59ed	2024-09-30	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Bryant Ranch Prepack	45e07bdd-78f9-4055-9de3-646e67de7eaf	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.	1d6be2b8-c670-b783-e063-6294a90ae503	2024-07-31	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	Aurobindo Pharma Limited	78e6bee2-7113-46cf-8c97-dc61b0f7b94f	2024-07-31	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	b0f73459-baeb-42a7-be48-2c3647d9b205	2024-07-30	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol sulfate	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	b478d9e9-9704-6af2-e053-2995a90aafd4	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	7043bc12-8a58-8ff8-e053-2a91aa0ab627	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	54d90668-5237-4330-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFA	ALBUTEROL SULFATE	NuCare Pharmaceuticals,Inc.	8c278b6f-d32b-b750-e053-2995a90ad7e9	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	A-S Medication Solutions	aa6d5c00-46a5-4f93-95e4-09319abfe71e	2024-05-07	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	A-S Medication Solutions	19867b61-77a2-46f1-97c7-7fadfec5882b	2024-05-07	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	A-S Medication Solutions	aff836e4-34f2-4ab9-bbf8-0c41ac848cb0	2024-05-07	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Prasco Laboratories	b25d9d6b-eb4c-452e-89ef-10e611deebd6	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
VENTOLIN HFA	ALBUTEROL SULFATE	GlaxoSmithKline LLC	d92c5d6b-ff10-4087-36a2-1cfc464cb967	2024-04-26	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	767a1504-1e04-1e06-e053-2a91aa0aa4b6	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC.	7f261a9b-65d9-408a-8609-c1b3809b8b4b	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC	4e48ccbe-3ec0-4bf2-be28-83eb9baa63d6	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate	ALBUTEROL SULFATE	Chartwell RX, LLC	922bf33b-4d55-4c35-9f68-72efbb17c14f	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATE	ALBUTEROL SULFATE	A-S Medication Solutions	7ad17b39-d2de-4108-abbf-cedd650c8edd	2024-02-18	Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFA	ALBUTEROL SULFATE	Asclemed USA, Inc.	a69489f7-4ffb-4cd1-b2d2-002f48e84f51	2023-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALBUTEROL SULFATE

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53002-1750	ProAir RespiClick	Albuterol Sulfate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1750	ProAir RespiClick	Albuterol Sulfate	RPK Pharmaceuticals, Inc.	NDA	Current
59310-117	ProAir Digihaler	albuterol sulfate	Teva Respiratory, LLC	NDA	Current
59310-117	ProAir Digihaler	albuterol sulfate	Teva Respiratory, LLC	NDA	Current
59310-117	ProAir Digihaler	albuterol sulfate	Teva Respiratory, LLC	NDA	Current
59310-117	ProAir Digihaler	albuterol sulfate	Teva Respiratory, LLC	NDA	Current
59310-117	ProAir Digihaler	albuterol sulfate	Teva Respiratory, LLC	NDA	Current
59310-117	ProAir Digihaler	albuterol sulfate	Teva Respiratory, LLC	NDA	Current
59310-117	ProAir Digihaler	albuterol sulfate	Teva Respiratory, LLC	NDA	Current
59310-540	ProAir Digihaler	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-540	ProAir Digihaler	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-540	ProAir Digihaler	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-540	ProAir Digihaler	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-540	ProAir Digihaler	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-540	ProAir Digihaler	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-580	ProAir RespiClick	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-580	ProAir RespiClick	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-580	ProAir RespiClick	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-580	ProAir RespiClick	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current
59310-580	ProAir RespiClick	Albuterol Sulfate	Teva Respiratory, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64774	SUPPL	2020-10-01
64763	SUPPL	2020-09-30
57161	SUPPL	2019-01-09
57160	SUPPL	2019-01-09
45292	SUPPL	2016-09-12
45264	SUPPL	2016-09-09
10481	SUPPL	2016-05-02
19669	SUPPL	2016-04-29
44928	ORIG	2016-03-02
22997	ORIG	2016-03-02
40487	ORIG	2015-04-28
32695	ORIG	2015-04-03
32696	ORIG	2015-03-10
51482	SUPPL	1900-01-01
51481	SUPPL	1900-01-01
51468	SUPPL	1900-01-01
51461	ORIG	1900-01-01
51459	ORIG	1900-01-01
51457	ORIG	1900-01-01