Application 020837

Type: NDA
Sponsor: OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.021% BASE	Yes	Yes
002	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.042% BASE	Yes	Yes
003	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.0103% BASE	Yes	Yes
004	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	SOLUTION;INHALATION	EQ 0.25% BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020837-001	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.021% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25
N020837-002	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.042% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	1999-03-25
N020837-003	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.0103% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2002-01-30
N020837-004	XOPENEX	LEVALBUTEROL HYDROCHLORIDE	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INHALATION	RLD	2003-07-18

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 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION		RLD	2002-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION		RLD	2003-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION		RLD	2002-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION		RLD	2003-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION		RLD	2002-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION		RLD	2003-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION		RLD	2002-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION		RLD	2003-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION		RLD	2002-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION		RLD	2003-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION		RLD	2002-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION		RLD	2003-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION		RLD	1999-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION		RLD	2002-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION		RLD	2003-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RLD, RS	1999-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RLD, RS	1999-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	RLD, RS	2002-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION	AN	RLD, RS	2003-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RLD, RS	1999-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RLD, RS	1999-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	RLD, RS	2002-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION	AN	RLD, RS	2003-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020837-001	XOPENEX	EQ 0.021% BASE	SOLUTION / INHALATION	AN	RLD, RS	1999-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-002	XOPENEX	EQ 0.042% BASE	SOLUTION / INHALATION	AN	RLD, RS	1999-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-003	XOPENEX	EQ 0.0103% BASE	SOLUTION / INHALATION	AN	RLD, RS	2002-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-004	XOPENEX	EQ 0.25% BASE	SOLUTION / INHALATION	AN	RLD, RS	2003-07-18	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-001	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-002	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-003	AN	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020837-004	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020837-001	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-002	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-003	AN	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020837-004	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020837-001	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-002	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-003	AN	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020837-004	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020837-001	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-002	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-003	AN	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-004	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020837-001	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020837-002	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020837-003	AN	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020837-004	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020837-001	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-002	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-003	AN	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-004	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-001	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-002	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-003	AN	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-004	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020837-001	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-002	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-003	AN	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-004	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020837-001	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-002	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-003	AN	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-004	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020837-001	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-002	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-003	AN	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-004	AN	1	`c0c555d07b60…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020837-001	6451289	2021-03-21		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-002	6451289	2021-03-21		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-003	6451289	2021-03-21		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020837-004	6451289	2021-03-21	Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N020837-001	6451289	2021-03-21		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-002	6451289	2021-03-21		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-003	6451289	2021-03-21		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020837-004	6451289	2021-03-21	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-001	6451289	2021-03-21		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-002	6451289	2021-03-21		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-003	6451289	2021-03-21		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020837-004	6451289	2021-03-21	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020837-001	6451289	2021-03-21		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-002	6451289	2021-03-21		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-003	6451289	2021-03-21		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020837-004	6451289	2021-03-21	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020837-001	6451289	2021-03-21		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-002	6451289	2021-03-21		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-003	6451289	2021-03-21		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020837-004	6451289	2021-03-21	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020837-001	6451289	2021-03-21		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-002	6451289	2021-03-21		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-003	6451289	2021-03-21		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020837-004	6451289	2021-03-21	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020837-001	6451289	2021-03-21		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020837-002	6451289	2021-03-21		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020837-003	6451289	2021-03-21		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020837-004	6451289	2021-03-21	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020837-001	6451289	2021-03-21		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020837-002	6451289	2021-03-21		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020837-003	6451289	2021-03-21		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020837-004	6451289	2021-03-21	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020837-001	6451289	2021-03-21		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020837-002	6451289	2021-03-21		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020837-003	6451289	2021-03-21		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020837-004	6451289	2021-03-21	Drug product	`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 · 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

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-171	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-172	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-173	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn	NDA	Current
17478-174	Xopenex	Levalbuterol Hydrochloride	Akorn, Inc.	NDA	Current
21695-153	Xopenex	levalbuterol hydrochloride	Rebel Distributors Corp	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-021	Levalbuterol Hydrochloride	Levalbuterol hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-022	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-022	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-022	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-022	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-022	Levalbuterol Hydrochloride	levalbuterol hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-023	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Prasco Laboratories	NDA	Current
66993-023	Levalbuterol hydrochloride	levalbuterol hydrochloride	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
70518-1227	Xopenex	Levalbuterol Hydrochloride	REMEDYREPACK INC.	NDA	Current
76204-002	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Ritedose Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
76204-003	Levalbuterol Hydrochloride	Levalbuterol Hydrochloride	Ritedose Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57234	SUPPL	2019-01-16
57120	SUPPL	2019-01-04
13572	SUPPL	2015-04-14
3522	SUPPL	2015-04-02
13571	SUPPL	2015-01-29
3521	SUPPL	2015-01-23
26010	SUPPL	2014-04-02
35478	SUPPL	2014-04-01
3520	SUPPL	2014-01-22
35477	SUPPL	2013-09-24
26009	SUPPL	2013-09-23
13570	SUPPL	2012-09-11
3519	SUPPL	2012-09-10
41743	SUPPL	2006-10-26
26008	SUPPL	2006-09-18
26007	SUPPL	2003-07-28
13569	SUPPL	2002-01-30
26006	ORIG	1999-03-25
20999	ORIG	1999-03-25
13568	ORIG	1999-03-25
51290	SUPPL	1900-01-01
51289	SUPPL	1900-01-01
51288	SUPPL	1900-01-01