Application 072637

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	TABLET;ORAL	EQ 4MG BASE	No	No
002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	TABLET;ORAL	EQ 2MG BASE	No	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
A072637-001	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB		1989-12-05
A072637-002	ALBUTEROL SULFATE	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB		1989-12-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072637-001	AB
A072637-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072637-001	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET / ORAL	AB	1989-12-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072637-002	ALBUTEROL SULFATE	EQ 2MG BASE	TABLET / ORAL	AB	1989-12-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A072637-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072637-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072637-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072637-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072637-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072637-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072637-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072637-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072637-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072637-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072637-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072637-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072637-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072637-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072637-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072637-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072637-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072637-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072637-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A072637-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072637-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072637-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072637-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072637-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072637-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072637-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072637-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072637-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072637-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072637-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072637-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A072637-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072637-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A072637-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072637-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072637-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072637-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A072637-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072637-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A072637-002	AB	1	`782e0a99824c…`

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 sulfate	ALBUTEROL SULFATE	Golden State Medical Supply, Inc.	a22af54a-c010-ab8b-e053-2a95a90a8862	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072637 application number: ANDA072637 ndc (product): 51407-368 ndc (product): 51407-367
albuterol sulfate	ALBUTEROL SULFATE	Sun Pharmaceutical Industries, Inc.	87b8cd3c-2849-4b50-b63e-9ea379165c07	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072637 application number: ANDA072637 ndc (product): 53489-176 ndc (product): 53489-177
Albuterol Sulfate	ALBUTEROL SULFATE	American Health Packaging	b0f73459-baeb-42a7-be48-2c3647d9b205	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072637 application number: ANDA072637 ndc (product): 68084-949 ndc (product): 68084-952

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-367	albuterol sulfate	albuterol sulfate	Golden State Medical Supply	ANDA	Current
51407-367	albuterol sulfate	albuterol sulfate	Golden State Medical Supply	ANDA	Current
51407-368	albuterol sulfate	albuterol sulfate	Golden State Medical Supply	ANDA	Current
51407-368	albuterol sulfate	albuterol sulfate	Golden State Medical Supply	ANDA	Current
53489-176	albuterol sulfate	albuterol sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
53489-177	albuterol sulfate	albuterol sulfate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63629-2638	albuterol sulfate	albuterol sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2638	albuterol sulfate	albuterol sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2736	albuterol sulfate	albuterol sulfate	Bryant Ranch Prepack	ANDA	Current
68084-949	albuterol sulfate	albuterol sulfate	American Health Packaging	ANDA	Current
68084-949	albuterol sulfate	albuterol sulfate	American Health Packaging	ANDA	Current
68084-949	Albuterol Sulfate	Albuterol Sulfate	American Health Packaging	ANDA	Current
68084-952	albuterol sulfate	albuterol sulfate	American Health Packaging	ANDA	Current
68084-952	albuterol sulfate	albuterol sulfate	American Health Packaging	ANDA	Current
68084-952	albuterol sulfate	albuterol sulfate	American Health Packaging	ANDA	Current
68788-0177	albuterol sulfate	albuterol sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-0255	albuterol sulfate	albuterol sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current