Application 077438

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	250MG	No	No
002	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	500MG	No	No
003	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	750MG	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	Approval date
A077438-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20
A077438-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20
A077438-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20

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	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077438-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077438-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077438-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077438-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077438-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077438-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077438-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077438-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077438-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077438-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077438-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077438-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077438-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077438-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077438-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077438-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077438-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077438-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077438-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077438-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077438-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077438-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077438-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077438-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077438-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077438-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077438-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077438-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077438-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077438-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077438-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077438-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077438-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077438-001	AB	1	`87673890dc5c…`

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	b9dc8bf3-97d9-4d1c-9a68-3ae553acdada	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Sagent Pharmaceuticals	699fbdb8-a6fd-476a-9b80-08197d869534	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	HAWAII REPACK, INC.	857f256c-88ac-4f73-9815-c2724edf2f1e	2026-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	2a4e97e0-0709-411b-92e8-6f7d669412e4	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	710c0c10-89a5-4954-8f74-acc187c5cf0f	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Chartwell RX, LLC	5c6c117c-9d91-48f4-9aaa-ee70b99218c2	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	f14cf651-a213-4a4f-adb9-f628562af27c	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Redpharm Drug	5261da15-1b6c-fbe2-e063-6394a90ad85e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Cardinal Health 107, LLC	070375be-3b67-4299-ae8f-4a7b157ac16f	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals, Inc.	bcad1dad-53aa-43dd-90f3-cc17cc9598d5	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals, Inc.	2a8676a9-247f-4fdb-b644-e9785d98771f	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	9f944b63-9b60-437a-ba57-d14d7976bc32	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
LEVOFLOXACIN	LEVOFLOXACIN	DIRECT RX	4f40d5fa-ebcc-516c-e054-00144ff8d46c	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOFLOXACIN generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	a5ae33ad-4703-4cb2-8618-6439c906be99	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Redpharm Drug	44f31105-5fc9-43d4-e063-6294a90a510f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	264a3f71-f23e-45e3-926a-421bcccf4e3d	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc.	7a12135e-cbad-4fe1-98f7-53c41d1f2a21	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	b8ac5047-5203-42c4-886b-dd0b08a1786f	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	16d51c1c-4144-4be7-9356-98fcee621ecd	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f2f090c2-3ee1-7689-e053-2995a90abe38	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5790	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5790	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5790	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5790	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5790	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5791	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5791	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5791	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5791	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5791	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5792	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5792	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5792	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5792	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
0781-5792	Levofloxacin	Levofloxacin	Sandoz Inc	ANDA	Current
35356-923	Levofloxacin	Levofloxacin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-1897	Levofloxacin	Levofloxacin	A-S Medication Solutions	ANDA	Current
50090-2001	Levofloxacin	Levofloxacin	A-S Medication Solutions	ANDA	Current
50436-6585	Levofloxacin	Levofloxacin	Unit Dose Services	ANDA	Current
55700-233	Levofloxacin	Levofloxacin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-233	Levofloxacin	Levofloxacin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-233	Levofloxacin	Levofloxacin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-003	Levofloxacin	Levofloxacin	Proficient Rx	ANDA	Current
63187-003	Levofloxacin	Levofloxacin	Proficient Rx	ANDA	Current
63187-004	Levofloxacin	Levofloxacin	Proficient Rx	ANDA	Current
63187-004	Levofloxacin	Levofloxacin	Proficient Rx	ANDA	Current
67296-0744	Levofloxacin	Levofloxacin	RedPharm Drug, Inc.	ANDA	Current
67296-0744	Levofloxacin	Levofloxacin	RedPharm Drug, Inc.	ANDA	Current
67296-0744	Levofloxacin	Levofloxacin	RedPharm Drug, Inc.	ANDA	Current
68788-7273	Levofloxacin	Levofloxacin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7273	Levofloxacin	Levofloxacin	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0450	Levofloxacin	Levofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-1549	Levofloxacin	Levofloxacin	REMEDYREPACK INC.	ANDA	Current
70518-1549	Levofloxacin	Levofloxacin	REMEDYREPACK INC.	ANDA	Current
70934-738	Levofloxacin	Levofloxacin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-0965	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0965	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0965	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current