Application 021918

Type: NDA
Sponsor: WRASER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETRAXAL	CIPROFLOXACIN HYDROCHLORIDE	SOLUTION/DROPS;OTIC	EQ 0.2% 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
N021918-001	CETRAXAL	CIPROFLOXACIN HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021918-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC		RLD, RS	2009-05-01	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021918-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021918-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021918-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021918-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021918-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021918-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021918-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021918-001	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021918-001	AB	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021918-001	AB	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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Coupler LLC	58388197-82f4-0953-e063-6294a90ac52a	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	b281a5c0-5f3e-4e6f-86ac-ed7794aac64c	2026-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Redpharm Drug	57e5832f-9168-1f24-e063-6294a90aaae6	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc	b7ac7e18-fd34-44df-8a0e-87dafbc7a2f5	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	HAWAII REPACK, INC.	0fe3becb-f90e-4187-a8e8-bd0de5a79ad2	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a2ffa81a-86c5-40b9-8fa0-c889801ef479	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a914512b-9a4a-4c53-ab7a-2e2b1ea8a012	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	47d1e4c5-f669-4aca-9e8c-0d6bb833b859	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aurobindo Pharma Limited	6a935846-3c97-4517-bc4e-2377f673285e	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Redpharm Drug	1ac4540c-d0f7-70bc-e063-6394a90a0f7a	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	4dd69fb7-802a-4278-a730-c722a3ca3521	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	d8b21832-b74f-4f85-a304-b907c9e01e72	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	9d83b127-ef13-4b2c-aa30-0f54937dc240	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	American Health Packaging	275de35b-5c97-4ff8-a571-42e23c1cd83e	2026-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Asclemed USA, Inc.	ae77a5c0-a2ae-770c-e053-2a95a90a6a96	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	26e2d370-f59c-40ae-9c1e-7f8bf1f9fde4	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	American Health Packaging	0fac4466-fbe5-49d2-96e3-e3ac2739bd5b	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	78641acd-eedf-4b68-bb18-da0874415f59	2026-03-27	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN	CIPROFLOXACIN HYDROCHLORIDE	DIRECT RX	a7e5174a-dd01-6050-e053-2a95a90add3f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Cipro	CIPROFLOXACIN HYDROCHLORIDE	Bayer HealthCare Pharmaceuticals Inc.	888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42195-550	Ciprofloxacin Otic	CIPROFLOXACIN	Xspire Pharma, Llc	NDA	Current
42195-550	Ciprofloxacin Otic	CIPROFLOXACIN	Xspire Pharma	NDA	Current
42195-550	Ciprofloxacin Otic	CIPROFLOXACIN	Xspire Pharma	NDA	Current
66992-450	CETRAXAL	Ciprofloxacin	Wraser Llc	NDA	Current
66992-450	CETRAXAL	Ciprofloxacin	Wraser Llc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24228	ORIG	2009-10-06
21870	ORIG	2009-10-06
37873	ORIG	2009-05-11
28841	ORIG	2009-05-06
64788	ORIG	1900-01-01
53212	ORIG	1900-01-01
53211	ORIG	1900-01-01
53210	ORIG	1900-01-01