Application 200875

Type: ANDA
Sponsor: TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.25% 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200875-001	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN		2014-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200875-001	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 2 · 42 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	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200875-001	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE	SOLUTION / INHALATION	AN	2014-09-11	`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	A200875-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200875-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200875-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200875-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200875-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200875-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200875-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200875-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200875-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200875-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200875-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200875-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200875-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200875-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200875-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200875-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200875-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200875-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200875-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200875-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200875-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200875-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200875-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200875-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200875-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200875-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200875-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200875-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200875-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200875-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200875-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200875-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200875-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200875-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200875-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200875-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200875-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200875-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200875-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200875-001	AN	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 · 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-4147	Levalbuterol	Levalbuterol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4147	Levalbuterol	Levalbuterol	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4147	Levalbuterol	Levalbuterol	Teva Pharmaceuticals USA, Inc.	ANDA	Current