Application 091397

Type: ANDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	INJECTABLE;INJECTION	EQ 250MG/50ML (EQ 5MG/ML)	No	No
002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	INJECTABLE;INJECTION	EQ 500MG/100ML (EQ 5MG/ML)	No	No
003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	INJECTABLE;INJECTION	EQ 750MG/150ML (EQ 5MG/ML)	No	No

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

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
A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	2013-08-08
A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	2013-08-08
A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	2013-08-08

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 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091397-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091397-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091397-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091397-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091397-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091397-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091397-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091397-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091397-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091397-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091397-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091397-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091397-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091397-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091397-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091397-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091397-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091397-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091397-001	AP	1	`782e0a99824c…`

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	Baxter Healthcare Corporation	70c87464-1806-480a-8ebd-3f02987ff436	2019-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 36000-048 ndc (product): 36000-046 ndc (product): 36000-047

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
36000-046	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-046	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-046	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-046	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-046	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-047	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-047	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-047	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-047	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-047	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-048	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-048	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-048	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-048	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-048	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-294	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-294	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-294	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-294	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-294	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-295	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-295	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-295	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-295	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-295	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-296	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-296	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-296	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-296	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-296	Levofloxacin	levofloxacin	Baxter Healthcare Corporation	ANDA	Current