Application 076717

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

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	No
002	CIPROFLOXACIN	CIPROFLOXACIN	INJECTABLE;INJECTION	400MG/40ML (10MG/ML)	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
A076717-001	CIPROFLOXACIN	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		RS	2009-12-22
A076717-002	CIPROFLOXACIN	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		RS	2009-12-22

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		RS	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		RS	2009-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		RS	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		RS	2009-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION		RS	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION		RS	2009-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076717-001	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076717-002	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE / INJECTION	AP		2009-12-22	`bb7c543d1eb4…`

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	A076717-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076717-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076717-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076717-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076717-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076717-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076717-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076717-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076717-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076717-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076717-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076717-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076717-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076717-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076717-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076717-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076717-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076717-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076717-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076717-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076717-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076717-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076717-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076717-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076717-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076717-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076717-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076717-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076717-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076717-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076717-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076717-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076717-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076717-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076717-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076717-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076717-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076717-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076717-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076717-002	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 1 of 8 · 146 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN	REMEDYREPACK INC.	44b6cefc-7638-4437-95e7-8f239f66a9d4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Redpharm Drug	57e5832f-9168-1f24-e063-6294a90aaae6	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFOLXACIN	REMEDYREPACK INC.	c527d138-e32c-418f-9573-a3d8a796279f	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	REMEDYREPACK INC.	c08b37c3-5f01-47ed-9508-02813bbd008b	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Northwind Health Company, LLC	4deea61e-f3ca-b35d-e063-6294a90a9d41	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	HAWAII REPACK, INC.	0fe3becb-f90e-4187-a8e8-bd0de5a79ad2	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
ciprofloxacin	CIPROFLOXACIN	HAWAII REPACK, INC	4caf49d9-b06f-4d57-aac3-cc64ae12cc95	2026-07-12	Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	St. Mary's Medical Park Pharmacy	348e810c-e572-f3d2-e063-6394a90a0855	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFOLXACIN	Asclemed USA, Inc.	c4eecdf8-9e50-4e44-aca1-b9c19317d52a	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	St. Mary's Medical Park Pharmacy	c32ccb5f-b9d7-0aff-e053-2995a90afe6d	2026-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
ciprofloxacin	CIPROFLOXACIN	Redpharm Drug	541bd97e-b2ff-09a8-e063-6394a90aee96	2026-06-13	Warnings, Adverse reactions	Name fallback brand name: ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a2ffa81a-86c5-40b9-8fa0-c889801ef479	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFOLXACIN	ST. MARY'S MEDICAL PARK PHARMACY	24c43000-7620-3869-e063-6394a90a9631	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a914512b-9a4a-4c53-ab7a-2e2b1ea8a012	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	5af16acc-51ce-41ed-b1c4-6b3fb38ef515	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN	Bryant Ranch Prepack	a05035e1-f941-4f7c-9321-91dd50ab149b	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	47d1e4c5-f669-4aca-9e8c-0d6bb833b859	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aurobindo Pharma Limited	6a935846-3c97-4517-bc4e-2377f673285e	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	4dd69fb7-802a-4278-a730-c722a3ca3521	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	d8b21832-b74f-4f85-a304-b907c9e01e72	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin