Application 021537

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPRODEX	CIPROFLOXACIN; DEXAMETHASONE	SUSPENSION/DROPS;OTIC	0.3%;0.1%	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
N021537-001	CIPRODEX	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021537-001	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	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC		RLD, RS	2003-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC		RLD, RS	2003-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC		RLD, RS	2003-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC		RLD, RS	2003-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021537-001	CIPRODEX	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	RLD, RS	2003-07-18	`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	N021537-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021537-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021537-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021537-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021537-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021537-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021537-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021537-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021537-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021537-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021537-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021537-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021537-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021537-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021537-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021537-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021537-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021537-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021537-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021537-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021537-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021537-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021537-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021537-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021537-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021537-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021537-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021537-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021537-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021537-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021537-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021537-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021537-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021537-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021537-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021537-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021537-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021537-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021537-001	6284804	2020-08-10				`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	6359016	2020-08-10				`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021537-001	9149486	2022-09-13	U-1578	Drug product	2015-11-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021537-001	9345714	2022-09-13	U-1578	Drug product	2016-06-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021537-001	9402805	2022-09-13	U-1679	Drug product	2016-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021537-001	9402805	2022-09-13	U-1578	Drug product	2016-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021537-001	8846650	2025-06-04	U-1578	Drug product	2014-10-03	`bb7c543d1eb4…`

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
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	Sandoz Inc	89fef4d2-7078-47f1-96bf-aca50b135a97	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021537 application number: NDA021537 ndc (product): 0781-6186

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-8533	CIPRODEX	ciprofloxacin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-8533	CIPRODEX	ciprofloxacin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-8533	CIPRODEX	ciprofloxacin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-8533	CIPRODEX	ciprofloxacin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0078-0799	CIPRODEX	ciprofloxacin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0799	CIPRODEX	ciprofloxacin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0799	CIPRODEX	ciprofloxacin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0799	CIPRODEX	ciprofloxacin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0799	CIPRODEX	ciprofloxacin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0781-6186	Ciprofloxacin and Dexamethasone	ciprofloxacin and dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-6186	Ciprofloxacin and Dexamethasone	ciprofloxacin and dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-6186	Ciprofloxacin and Dexamethasone	ciprofloxacin and dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
21695-969	CIPRODEX	ciprofloxacin and dexamethasone	Rebel Distributors Corp	NDA	Current
63629-8797	Ciprofloxacin and Dexamethasone	ciprofloxacin and dexamethasone	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8797	Ciprofloxacin and Dexamethasone	ciprofloxacin and dexamethasone	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68071-1629	CIPRODEX	ciprofloxacin and dexamethasone	NuCare Pharmaceuticals,Inc.	NDA	Current
71205-309	CIPRODEX	ciprofloxacin and dexamethasone	Proficient Rx LP	NDA	Current
71205-309	CIPRODEX	ciprofloxacin and dexamethasone	Proficient Rx LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75355	SUPPL	2023-09-05
65160	SUPPL	2020-11-06
65155	SUPPL	2020-11-04
57796	SUPPL	2019-02-22
57767	SUPPL	2019-02-22
15723	SUPPL	2015-12-15
28058	SUPPL	2015-12-14
21725	SUPPL	2015-08-25
42203	ORIG	2005-05-02
28057	ORIG	2003-07-28