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 3 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	99918613-7936-47dd-8565-9cd6c0cc22e3	2025-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Asclemed USA, Inc.	509b932e-9229-42c0-8a4c-f3257ffdca49	2025-03-29	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30caadee-3255-e0e3-e063-6294a90a8061	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	Advagen Pharma Limited	74af98f1-eb6d-473b-94a9-67920dba8c3d	2025-03-11	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1cb05412-372e-4b49-92e1-532caa05f38f	2025-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	d17b0e87-b555-4dfb-e053-2a95a90aa5ef	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	1b54c195-71ba-2523-e063-6294a90ada73	2025-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Carlsbad Technology, Inc.	37527eca-115e-4582-88cd-bba851ac6069	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5cf0f572-48fc-6a3a-e053-2991aa0a8437	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6301febb-01aa-1af5-e053-2991aa0aa309	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	ec3a3dcf-b9c9-432e-adfe-4b30cade8931	2024-11-07	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	b283d662-9be1-49c7-be03-cb21055314c1	2024-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	694b79f6-599f-4a71-bf02-d0d09767a735	2024-10-01	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
CILOXAN	CIPROFLOXACIN HYDROCHLORIDE	Sandoz Inc	09ca5374-2a16-4a95-91b3-70591d78254e	2024-07-30	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	54c73290-bd89-3453-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	ec337816-4f48-4d04-b91d-60f9f5f634da	2024-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	8eef4f14-e7ef-41be-be57-7993b333e8a9	2023-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	e04dfddd-6177-4c2e-8f42-acd65848e6e2	2022-12-01	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HCl Ophthalmic	CIPROFLOXACIN HYDROCHLORIDE	Altaire Pharmaceuticals Inc.	41363a06-d6f5-4bc6-b0e9-34e5616ae387	2022-10-28	Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	a093ca6e-9963-4eea-b60d-6e2f148192ec	2022-07-01	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