Application 077689

Type: ANDA
Sponsor: RISING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.3% BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077689-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2006-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077689-001	AT

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 2 · 43 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
2026-09-14 22:38:34	2026-08	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077689-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2006-12-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077689-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077689-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077689-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077689-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077689-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077689-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077689-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077689-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077689-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077689-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077689-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077689-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077689-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077689-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077689-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077689-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077689-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077689-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077689-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077689-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077689-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077689-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077689-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077689-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077689-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077689-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077689-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077689-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077689-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077689-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077689-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077689-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077689-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077689-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077689-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077689-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077689-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077689-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077689-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077689-001	AT	1	`f41ea6bd6efb…`

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 4 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	9ee1f252-a64e-4b72-a6f7-60298e827222	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Sandoz Inc	ab52b14d-345b-47ff-a832-465caddd3801	2019-07-18	Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin Hydrochloride generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	df24efa3-c9a0-4f40-92ce-cc71c708931b	2018-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4e74496f-4dca-4471-be32-c0a14bc62750	2018-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-120	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-120	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Rising Pharmaceuticals, Inc.	ANDA	Current
45865-721	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Medsource Pharmaceuticals	ANDA	Current
45865-721	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Medsource Pharmaceuticals	ANDA	Current
50090-0881	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-2310	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50436-0210	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Unit Dose Services	ANDA	Current
53002-1320	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1320	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-113	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-113	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-421	CIPROFLOXACIN	CIPROFLOXACIN	Direct Rx	ANDA	Current
61919-421	CIPROFLOXACIN	ciprofloxacin hydrochloride solution	DIRECT RX	ANDA	Current
63187-150	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
63187-150	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	ANDA	Current
68071-1530	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1616	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9391	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9391	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0340	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0522	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0522	Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current