Application 020369

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	OINTMENT;OPHTHALMIC	EQ 0.3% BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020369-001	CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC		RLD, RS	1998-03-30

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020369-001	CILOXAN	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	RLD, RS	1998-03-30	`e64feba35796…`

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
CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	Sandoz Inc	09ca5374-2a16-4a95-91b3-70591d78254e	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020369 application number: NDA020369

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0654	CILOXAN	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0654	CILOXAN	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0654	CILOXAN	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0654	CILOXAN	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0654	CILOXAN	ciprofloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0078-0841	CILOXAN	ciprofloxacin hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0841	CILOXAN	ciprofloxacin hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47269	SUPPL	2017-02-21
47268	SUPPL	2017-02-21
34564	SUPPL	2004-07-21
24856	SUPPL	2004-07-21
12494	SUPPL	2004-07-21
2402	SUPPL	2004-07-21
34563	SUPPL	2003-10-07
12493	SUPPL	2003-10-07
24855	SUPPL	2003-08-28
2401	SUPPL	2003-08-28
41303	ORIG	2003-05-15
12492	ORIG	1998-03-30
2400	ORIG	1998-03-30