Application 075928

Type: ANDA
Sponsor: RUBICON

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
A075928-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2004-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075928-001	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	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2004-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075928-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2004-06-09	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075928-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075928-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075928-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075928-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075928-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075928-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075928-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075928-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075928-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075928-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075928-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075928-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075928-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075928-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075928-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075928-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075928-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075928-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075928-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075928-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075928-001	AT	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075928-001	AT	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	Advagen Pharma Limited	74af98f1-eb6d-473b-94a9-67920dba8c3d	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075928 application number: ANDA075928

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8834	ORIG	2004-06-10
31047	ORIG	2003-04-10