Application 078062

Type: ANDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPROFLOXACIN	CIPROFLOXACIN	INJECTABLE;INJECTION	200MG/20ML (10MG/ML)	No	Yes
002	CIPROFLOXACIN	CIPROFLOXACIN	INJECTABLE;INJECTION	400MG/40ML (10MG/ML)	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078062-001	CIPROFLOXACIN	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29
A078062-002	CIPROFLOXACIN	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29

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 · 86 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
2026-09-14 22:38:34	2026-08	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION			2008-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078062-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078062-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP	RS	2008-04-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A078062-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078062-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078062-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078062-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078062-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078062-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078062-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078062-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078062-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078062-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078062-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078062-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078062-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078062-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078062-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078062-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078062-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078062-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078062-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078062-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078062-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078062-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078062-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078062-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078062-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078062-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078062-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078062-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078062-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078062-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078062-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078062-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078062-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078062-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078062-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078062-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078062-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078062-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078062-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078062-002	AP	1	`5aa47cf7b7d7…`

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 5 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFOLXACIN	Proficient Rx LP	0ce2221d-940f-4c07-ba2e-fccb491f6b9b	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	69df48cc-76b6-428e-891a-c25e07d785f8	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a5ecc693-b8fd-4a7a-8040-e56f801c9353	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFOLXACIN	Coupler LLC	3134401f-72a3-6c37-e063-6294a90a8fa9	2025-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
ciprofloxacin	CIPROFLOXACIN	Advanced Rx of Tennessee, LLC	30cb2b42-aa4b-8cec-e063-6394a90aa615	2025-03-20	Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Coupler LLC	2fff7a38-2c4e-d343-e063-6294a90aca3c	2025-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Umasuto, LLC	0c355077-7361-41d0-9e82-eb31beaf5daa	2025-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1cb05412-372e-4b49-92e1-532caa05f38f	2025-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	Direct_Rx	2efbda2a-fc97-b7c5-e063-6294a90a362d	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	d17b0e87-b555-4dfb-e053-2a95a90aa5ef	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	1b54c195-71ba-2523-e063-6294a90ada73	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	fa32aafd-e3f5-4be6-9413-c7663c1c2cec	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	5723eaf9-8659-4730-b792-4e4c33690ccb	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	PD-Rx Pharmaceuticals, Inc.	d275175c-691a-4d09-bbb7-50ee819e6727	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Carlsbad Technology, Inc.	37527eca-115e-4582-88cd-bba851ac6069	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFOLXACIN	Coupler LLC	2d6ad813-7773-9e20-e063-6294a90a112d	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFOLXACIN	Advanced Rx of Tennessee, LLC	2d324cb1-8567-55e5-e063-6294a90aa5d9	2025-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN TABLETS	Bryant Ranch Prepack	7030109d-5ce0-43f1-a5ed-16a3562acd40	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN TABLETS	Bryant Ranch Prepack	8d6ec3ee-2205-4d78-bc48-d39f371797c1	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	Redpharm Drug	17435f05-f04d-e792-e063-6294a90af145	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
36000-010	Ciprofloxacin	Ciprofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-010	Ciprofloxacin	Ciprofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-010	Ciprofloxacin	Ciprofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-010	Ciprofloxacin	Ciprofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-011	Ciprofloxacin	Ciprofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-011	Ciprofloxacin	Ciprofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-011	Ciprofloxacin	Ciprofloxacin	Baxter Healthcare Corporation	ANDA	Current
36000-011	Ciprofloxacin	Ciprofloxacin	Baxter Healthcare Corporation	ANDA	Current