Application 078252

Type: ANDA
Sponsor: INFORLIFE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	INJECTABLE;INJECTION	200MG/100ML	No	No
002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	INJECTABLE;INJECTION	400MG/200ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	200MG/100ML	INJECTABLE / INJECTION	AP		2008-03-18
A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	400MG/200ML	INJECTABLE / INJECTION	AP		2008-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078252-001	AP
A078252-002	AP

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 · 84 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	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078252-001	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	AP	2008-03-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078252-002	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML	INJECTABLE / INJECTION	AP	2008-03-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078252-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078252-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078252-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078252-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078252-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078252-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078252-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078252-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078252-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078252-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078252-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078252-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078252-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078252-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078252-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078252-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078252-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078252-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078252-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078252-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078252-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078252-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078252-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078252-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078252-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078252-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078252-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078252-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078252-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078252-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078252-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078252-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078252-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078252-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078252-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078252-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078252-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078252-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078252-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078252-002	AP	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin in Dextrose	CIPROFLOXACIN	ProPharma Distribution	42c758be-4d44-018a-e063-6294a90ae041	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078252 application number: ANDA078252
Ciprofloxacin in Dextrose	CIPROFLOXACIN	Hospira, Inc.	cbbbf939-3219-4515-a48e-ca264daa4d07	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078252 application number: ANDA078252 ndc (product): 0409-2300 ndc (product): 0409-3300
Ciprofloxacin	CIPROFLOXACIN	Sagent Pharmaceuticals	7049f870-6741-4a67-8033-398c36126a06	2022-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078252 application number: ANDA078252 ndc (product): 25021-114

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-2300	Ciprofloxacin in Dextrose	ciprofloxacin	Hospira, Inc	ANDA	Current
0409-3300	Ciprofloxacin in Dextrose	ciprofloxacin	Hospira, Inc	ANDA	Current
0781-3239	Ciprofloxacin	Ciprofloxacin	Sandoz Inc	ANDA	Current
0781-3240	Ciprofloxacin	Ciprofloxacin	Sandoz Inc	ANDA	Current
25021-114	Ciprofloxacin	ciprofloxacin	Sagent Pharmaceuticals	ANDA	Current
25021-114	Ciprofloxacin	ciprofloxacin	Sagent Pharmaceuticals	ANDA	Current
25021-114	Ciprofloxacin	ciprofloxacin	Sagent Pharmaceuticals	ANDA	Current
25021-114	Ciprofloxacin	ciprofloxacin	Sagent Pharmaceuticals	ANDA	Current
25021-114	Ciprofloxacin	ciprofloxacin	Sagent Pharmaceuticals	ANDA	Current
25021-192	Ciprofloxacin	ciprofloxacin	Sagent Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31351	ORIG	2008-03-19