Application 207046

Type: ANDA
Sponsor: APPCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	TABLET;ORAL	EQ 2MG BASE	No	No
002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	TABLET;ORAL	EQ 4MG BASE	No	No

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

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
A207046-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		2018-06-29
A207046-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB		2018-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207046-001	AB
A207046-002	AB

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207046-001	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	2018-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207046-002	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	2018-06-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A207046-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207046-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207046-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207046-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207046-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207046-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207046-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207046-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207046-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207046-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207046-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207046-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207046-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207046-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207046-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207046-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207046-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207046-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207046-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207046-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207046-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207046-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207046-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207046-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207046-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207046-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207046-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207046-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207046-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207046-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207046-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207046-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207046-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207046-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207046-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207046-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207046-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207046-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207046-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207046-002	AB	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albuterol	ALBUTEROL	Bryant Ranch Prepack	601a18ed-d66e-498f-a804-f1a3330827d4	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207046 application number: ANDA207046 ndc (product): 63629-2611
Albuterol	ALBUTEROL	Rising Pharma Holdings, Inc.	40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207046 application number: ANDA207046 ndc (product): 64980-442 ndc (product): 64980-443
Albuterol	ALBUTEROL	Proficient Rx LP	895dff1c-d21c-4470-b021-a5b68364c1ec	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207046 application number: ANDA207046 ndc (product): 71205-899 ndc (product): 71205-898

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-2611	Albuterol	albuterol	Bryant Ranch Prepack	ANDA	Current
64980-442	Albuterol	albuterol	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-442	Albuterol	albuterol	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-443	Albuterol	albuterol	Rising Pharmaceuticals, Inc.	ANDA	Current
64980-443	Albuterol	albuterol	Rising Pharmaceuticals, Inc.	ANDA	Current
71205-898	Albuterol	albuterol	Proficient Rx LP	ANDA	Current
71205-898	Albuterol	albuterol	Proficient Rx LP	ANDA	Current
71205-898	Albuterol	albuterol	Proficient Rx LP	ANDA	Current
71205-899	Albuterol	albuterol	Proficient Rx LP	ANDA	Current
71205-899	Albuterol	albuterol	Proficient Rx LP	ANDA	Current
71205-899	Albuterol	albuterol	Proficient Rx LP	ANDA	Current