Application 207820

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.0103% BASE	No	No
002	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.021% BASE	No	No
003	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.042% BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A207820-001	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05
A207820-002	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05
A207820-003	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207820-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207820-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	2018-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207820-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	2018-11-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A207820-001	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207820-002	AN	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207820-003	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207820-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207820-002	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207820-003	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207820-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207820-002	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207820-003	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207820-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207820-002	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207820-003	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207820-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207820-002	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207820-003	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207820-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207820-002	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207820-003	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207820-001	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207820-002	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207820-003	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207820-001	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207820-002	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207820-003	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207820-001	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207820-002	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207820-003	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207820-001	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207820-002	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207820-003	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207820-001	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207820-002	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207820-003	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207820-001	AN	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207820-002	AN	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207820-003	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207820-001	AN	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207820-002	AN	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207820-003	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207820-001	AN	1	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levalbuterol Inhalation Solution	LEVALBUTEROL INHALATION SOLUTION	Sun Pharmaceutical Industries, Inc.	85a59e0c-ff09-49a6-b7b8-616e033107b4	2020-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207820 application number: ANDA207820 ndc (product): 47335-746 ndc (product): 47335-743 ndc (product): 47335-753

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-094	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	NorthStar RxLLC	ANDA	Current
16714-095	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	NorthStar RxLLC	ANDA	Current
16714-096	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	NorthStar RxLLC	ANDA	Current
47335-743	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-743	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-743	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-746	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-746	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-746	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-753	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-753	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-753	Levalbuterol Inhalation Solution	Levalbuterol Inhalation Solution	Sun Pharmaceutical Industries, Inc.	ANDA	Current
68071-2340	Levalbuterol	Levalbuterol	NuCare Pharmaceuticals,Inc.	ANDA	Current