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 6 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CIPROFLOXACIN	CIPROFLOXACIN	Direct Rx	d88a22f4-2f61-17f2-e053-2995a90acd14	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: CIPROFLOXACIN generic name: CIPROFLOXACIN
CIPROFLOXACIN	CIPROFLOXACIN	DirectRx	d23e359d-6d12-38f6-e053-2a95a90a0a88	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: CIPROFLOXACIN generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	DirectRx	d358eb18-f4d0-e9ba-e053-2a95a90a435d	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Golden State Medical Supply, Inc.	2e1addcf-6d5b-46c8-812b-558fd847f005	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFOLXACIN	Bryant Ranch Prepack	ab16bacd-f73f-462e-82b2-b0abb1c49cec	2024-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	Hikma Pharmaceuticals USA Inc.	3b3d22dc-df09-4910-8c9b-1204eeedbd68	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFOLXACIN	Solco Healthcare US, LLC	b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	Teva Pharmaceuticals USA, Inc.	3e4402d4-e0d3-9846-3e81-ed46f34137fe	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Amneal Pharmaceuticals NY LLC	b996e81b-36ec-4ad7-a7c4-bc6700a06648	2024-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	b283d662-9be1-49c7-be03-cb21055314c1	2024-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFOLXACIN	A-S Medication Solutions	cfe9e173-1d3a-4455-a9d3-fb953bebbe37	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFOLXACIN	NuCare Pharmaceuticals, Inc.	238284a8-b38e-82af-e063-6394a90a79e1	2024-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
ciprofloxacin	CIPROFLOXACIN	A-S Medication Solutions	766251ac-2040-4a79-9ca5-a1e5f1e01cb5	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFOLXACIN	Bryant Ranch Prepack	c9108da9-c271-4e9e-a035-8dd3019e8cf3	2024-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFOLXACIN	Bryant Ranch Prepack	2b8288a2-18bf-423c-b175-33174be729d4	2024-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals, Inc.	44e5582d-fff1-0ec9-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals, Inc.	46dedf2c-26de-0f46-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	b0136d72-0869-2da0-e053-2995a90af70a	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	b064286b-fedc-be68-e053-2995a90aae52	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	NuCare Pharmaceuticals,Inc.	7def5a45-6725-0521-e053-2991aa0a0bda	2024-06-12	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