Application 204968

Type: ANDA
Sponsor: HEC PHARM

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 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	TE codes	Approval date
A204968-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05
A204968-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05
A204968-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204968-001	AB
A204968-002	AB
A204968-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204968-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2019-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204968-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2019-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204968-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2019-02-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204968-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204968-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204968-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204968-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204968-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204968-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204968-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204968-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204968-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204968-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204968-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204968-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204968-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204968-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204968-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204968-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204968-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204968-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204968-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204968-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204968-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204968-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204968-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204968-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204968-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204968-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204968-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204968-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204968-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204968-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204968-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204968-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204968-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204968-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204968-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204968-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204968-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204968-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204968-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204968-001	AB	1	`301d65b070ca…`

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 4 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	Lupin Pharmaceuticals, Inc.	4be13bd5-0c39-43c3-9232-b1226ccd4dbc	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	631523e7-7d67-0cc3-e053-2a91aa0abb62	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Gland Pharma Limited	95479f18-76dc-41cf-a359-922febeed0f2	2024-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Dr. Reddy's Laboratories Limited	9b59428a-a23a-b2d9-982f-98f8a1ed381f	2024-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Viona Pharmaceuticals Inc	0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Aurobindo Pharma Limited	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN IN 5% DEXTROSE	Eugia US LLC	7d3f83bf-2db7-4657-9538-406adf321ad5	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin
Levofloxacin	LEVOFLOXACIN	ANI Pharmaceuticals, Inc.	a894e40b-77e4-439b-b0f8-9a5cc7a1dd90	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Eugia US LLC	4d400bf9-988f-42ec-93f1-e71a93a324b2	2024-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	72cb9372-e9f8-3ca1-e053-2a91aa0ad820	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LLEVOFLOXACIN	Advanced Rx Pharmacy of Tennessee, LLC	19afbe98-484c-c980-e063-6294a90acdc6	2024-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin
Levofloxacin	LEVOFLOXACIN	Fresenius Kabi USA, LLC	eb30fafa-bbb9-458f-89df-ae610fa6aa96	2024-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Asclemed USA, Inc.	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	2024-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Macleods Pharmaceuticals Limited	fc165a6d-24b0-4753-a7ac-94a134dca0d3	2023-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	95149cfb-1a71-42b7-b50d-9a2e94334339	2022-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	30958610-3803-45e6-aa3c-d256decbe6e4	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Hikma Pharmaceuticals USA Inc.	e680c759-16c5-4532-9c9c-f42c8c3df74a	2019-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Hikma Pharmaceuticals USA Inc.	f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5	2019-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Baxter Healthcare Corporation	70c87464-1806-480a-8ebd-3f02987ff436	2019-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48792-7814	levofloxacin	levofloxacin	Sunshine Lake Pharma CO., LTD.	ANDA	Current
48792-7815	levofloxacin	levofloxacin	Sunshine Lake Pharma CO., LTD.	ANDA	Current
48792-7816	levofloxacin	levofloxacin	Sunshine Lake Pharma CO., LTD.	ANDA	Current