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 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
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 · 43 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
2026-09-14 22:38:34	2026-08	N021918-001	CETRAXAL	EQ 0.2% BASE	SOLUTION/DROPS / OTIC	AB	RLD, RS	2009-05-01	`84e616aacf4f…`
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…`

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	N021918-001	AB	1	`84e616aacf4f…`
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 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 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 · 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