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 1.

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205636-001	PROAIR RESPICLICK	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD, RS	2015-03-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205636-002	PROAIR DIGIHALER	EQ 0.09MG BASE/INH	POWDER, METERED / INHALATION	RLD	2018-12-21	`782e0a99824c…`

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ProAir RespiClick	ALBUTEROL SULFATE	Teva Respiratory, LLC	9324e2eb-26fd-4f14-9f10-e5aa467306f4	2022-09-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205636 application number: NDA205636 ndc (product): 59310-580
ProAir Digihaler	ALBUTEROL SULFATE	Teva Respiratory, LLC	667ce3ec-5217-4b10-b712-f3e54fbbf087	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205636 application number: NDA205636 ndc (product): 59310-540 ndc (product): 59310-117

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