Application 020805

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	SUSPENSION/DROPS;OTIC	EQ 0.2% BASE;1%	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
N020805-001	CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020805-001	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	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	1998-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020805-001	CIPRO HC	EQ 0.2% BASE;1%	SUSPENSION/DROPS / OTIC		RLD, RS	1998-02-10	`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	N020805-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020805-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020805-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020805-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020805-001	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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ciprofloxacin hydrochloride and hydrocortisone	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	Sandoz Inc	c0881bbe-cc95-45d4-9878-3bc8946eff26	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	A-S Medication Solutions	d2c40b07-dc39-46c6-8ea1-b288589a46d1	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	Sandoz Inc	b26594a3-2adf-4954-8be0-5bd6f8de9671	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	A-S Medication Solutions	ab640d62-f470-4b50-818f-0c0a33904743	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805 ndc (product): 50090-6043
CIPRO HC	CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE	Asclemed USA, Inc.	eafad445-2735-434b-a1c6-e1c6b201d2cf	2022-09-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020805 application number: NDA020805 ndc (product): 76420-273

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-8531	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	Alcon Laboratories, Inc.	NDA	Current
0065-8531	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	Alcon Laboratories, Inc.	NDA	Current
0065-8531	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	Alcon Laboratories, Inc.	NDA	Current
0065-8531	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	Alcon Laboratories, Inc.	NDA	Current
0065-8531	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	Alcon Laboratories, Inc.	NDA	Current
0078-0855	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	Novartis Pharmaceuticals Corporation	NDA	Current
50090-1656	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	A-S Medication Solutions	NDA	Current
50090-1656	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	A-S Medication Solutions	NDA	Current
50090-1656	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	A-S Medication Solutions	NDA	Current
50090-1656	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	A-S Medication Solutions	NDA	Current
50090-6043	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	A-S Medication Solutions	NDA	Current
76420-273	CIPRO	ciprofloxacin hydrochloride and hydrocortisone	Asclemed USA, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47686	SUPPL	2017-03-24
47625	SUPPL	2017-03-21
41714	ORIG	1998-02-10
13467	ORIG	1998-02-10
3397	ORIG	1998-02-10