Application 078171

Type: ANDA
Sponsor: CIPLA

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 42.

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	TE codes	Approval date
A078171-001	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13
A078171-002	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13
A078171-003	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078171-001	AN
A078171-002	AN
A078171-003	AN

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 · 126 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	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-002	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE	SOLUTION / INHALATION	AN	2013-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-003	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE	SOLUTION / INHALATION	AN	2013-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078171-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	2013-12-13	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A078171-001	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078171-002	AN	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078171-003	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078171-001	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078171-002	AN	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078171-003	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-001	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-002	AN	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078171-003	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078171-001	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078171-002	AN	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078171-003	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-001	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-002	AN	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078171-003	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-001	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-002	AN	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078171-003	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-001	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-002	AN	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078171-003	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-001	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-002	AN	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078171-003	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-001	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-002	AN	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078171-003	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-001	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-002	AN	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078171-003	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078171-001	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078171-002	AN	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078171-003	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-001	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-002	AN	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078171-003	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-001	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-002	AN	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078171-003	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078171-001	AN	1	`1e350fbaab3a…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Redpharm Drug	58beb877-b94a-bbe0-e063-6294a90a7fe0	2026-08-11	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Redpharm Drug	56cb1f4b-ddf4-0661-e063-6394a90a9c45	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Ritedose Pharmaceuticals, LLC	d6998949-e1cb-4c86-a480-c0dfd9cb75b5	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	e7e3d858-6a0d-482c-b71b-de90d3ef3169	2023-09-14	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	d4080fc5-50d6-49a9-8a63-7769d201968d	2023-09-14	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Bryant Ranch Prepack	2f416dc8-62aa-4b6b-a745-2c8a72bb763d	2023-09-13	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	A-S Medication Solutions	262c0b8b-8461-4bdf-b272-c829d33fd451	2023-02-28	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Burel Pharmaceuticals, LLC	737fe40b-798b-4d7f-bec9-7af952018ab5	2021-07-01	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE
Levalbuterol	LEVALBUTEROL HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	e5c8368a-49f9-45cf-9d42-a871f005edb9	2019-06-29	Warnings, Adverse reactions	Name fallback generic name: LEVALBUTEROL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-409	levalbuterol inhalation	levalbuterol inhalation 1.25mg/3mL	Dr. Reddy	ANDA	Current
43598-409	levalbuterol inhalation	levalbuterol inhalation 1.25mg/3mL	Dr. Reddy	ANDA	Current
43598-410	levalbuterol inhalation	levalbuterol inhalation 0.63mg/3mL	Dr. Reddy	ANDA	Current
43598-410	levalbuterol inhalation	levalbuterol inhalation 0.63mg/3mL	Dr. Reddy	ANDA	Current
43598-412	levalbuterol inhalation	levalbuterol inhalation 0.31mg/3mL	Dr. Reddy	ANDA	Current
43598-412	levalbuterol inhalation	levalbuterol inhalation 0.31mg/3mL	Dr. Reddy	ANDA	Current