Application 202328

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOFLOXACIN	LEVOFLOXACIN	INJECTABLE;INJECTION	EQ 500MG/20ML (EQ 25MG/ML)	No	Yes
002	LEVOFLOXACIN	LEVOFLOXACIN	INJECTABLE;INJECTION	EQ 750MG/30ML (EQ 25MG/ML)	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202328-001	LEVOFLOXACIN	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24
A202328-002	LEVOFLOXACIN	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION			2013-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

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	A202328-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202328-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202328-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202328-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202328-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202328-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202328-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202328-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202328-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202328-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202328-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202328-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202328-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202328-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202328-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202328-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202328-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202328-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202328-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202328-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202328-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202328-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202328-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202328-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202328-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202328-002	AP	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202328-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202328-002	AP	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	Eugia US LLC	4d400bf9-988f-42ec-93f1-e71a93a324b2	2024-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202328 application number: ANDA202328 ndc (product): 55150-156 ndc (product): 55150-157

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
55150-156	Levofloxacin	Levofloxacin	AuroMedics Pharma LLC	ANDA	Current
55150-156	Levofloxacin	Levofloxacin	AuroMedics Pharma LLC	ANDA	Current
55150-156	Levofloxacin	Levofloxacin	AuroMedics Pharma LLC	ANDA	Current
55150-157	Levofloxacin	Levofloxacin	AuroMedics Pharma LLC	ANDA	Current
55150-157	Levofloxacin	Levofloxacin	AuroMedics Pharma LLC	ANDA	Current
55150-157	Levofloxacin	Levofloxacin	AuroMedics Pharma LLC	ANDA	Current