Application 020503

Type: NDA
Sponsor: 3M DRUG DELIVERY

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020503-001	PROVENTIL-HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020503-001	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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	BX	RLD, RS	1996-08-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020503-001	PROVENTIL-HFA	EQ 0.09MG BASE/INH	AEROSOL, METERED / INHALATION	AB1	RLD, RS	1996-08-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020503-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020503-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020503-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020503-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020503-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020503-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020503-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020503-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020503-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020503-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020503-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020503-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020503-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020503-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020503-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020503-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020503-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020503-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020503-001	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020503-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020503-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020503-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020503-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020503-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020503-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020503-001	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020503-001	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020503-001	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020503-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020503-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020503-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020503-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020503-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020503-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020503-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020503-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020503-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020503-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020503-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020503-001	AB1	1	`e64feba35796…`

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	ALBUTEROL SULFATE	Preferred Pharmaceuticals Inc.	d6acb5a7-555a-463a-ae65-2911d6789b42	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503 ndc (product): 68788-7996
Albuterol Sulfate	ALBUTEROL SULFATE	Sandoz Inc	f8a2c4b7-a162-48ab-90b0-350e4da25c66	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503 ndc (product): 0781-7296
Albuterol Sulfate	ALBUTEROL SULFATE	REMEDYREPACK INC.	32dbec5e-044a-40b6-9b88-e1396c4b4b6e	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503
Albuterol Sulfate	ALBUTEROL SULFATE	Proficient Rx LP	07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020503 application number: NDA020503

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0085-1132	Proventil HFA	Albuterol Sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1132	Proventil HFA	Albuterol Sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1132	Proventil HFA	Albuterol Sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1132	Proventil HFA	Albuterol Sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1132	Proventil HFA	Albuterol Sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0085-1132	Proventil HFA	Albuterol Sulfate	Merck Sharp & Dohme Corp.	NDA	Current
0254-1007	Albuterol Sulfate	Albuterol Sulfate	Par Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
0254-1007	Albuterol Sulfate	Albuterol Sulfate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-1007	Albuterol Sulfate	Albuterol Sulfate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-1007	Albuterol Sulfate	Albuterol Sulfate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-1007	Albuterol Sulfate	Albuterol Sulfate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0781-7296	Albuterol Sulfate	Albuterol Sulfate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7296	Albuterol Sulfate	Albuterol Sulfate	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
42254-004	Proventil HFA	Albuterol Sulfate	Rebel Distributors Corp.	NDA	Current
50090-0624	Proventil HFA	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
50090-4326	Proventil HFA	Albuterol Sulfate	A-S Medication Solutions	NDA	Current
55700-908	Albuterol Sulfate	Albuterol Sulfate	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
55700-908	Albuterol Sulfate	Albuterol Sulfate	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
63629-8468	Albuterol Sulfate	Albuterol Sulfate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8468	Albuterol Sulfate	Albuterol Sulfate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
66758-959	Proventil HFA	Albuterol Sulfate	Sandoz	NDA	Current
66758-959	Proventil HFA	Albuterol Sulfate	Sandoz	NDA	Current
66758-959	Proventil HFA	Albuterol Sulfate	Sandoz	NDA	Current
66758-959	Proventil HFA	Albuterol Sulfate	Sandoz	NDA	Current
68071-2367	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-2505	Albuterol Sulfate	Albuterol Sulfate	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68788-7881	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7996	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7996	Albuterol Sulfate	Albuterol Sulfate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49856	SUPPL	2017-09-26
49854	SUPPL	2017-09-25
41399	SUPPL	2015-03-10
34720	SUPPL	2012-06-11
2611	SUPPL	2012-06-07
2610	SUPPL	2009-11-12
34719	SUPPL	2009-09-17
25057	SUPPL	2004-02-03
41398	SUPPL	1999-06-02
2609	SUPPL	1999-06-02
34718	SUPPL	1998-09-23
25056	SUPPL	1998-09-23
20685	SUPPL	1998-09-23