Application 022428

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOXEZA	MOXIFLOXACIN HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% 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
N022428-001	MOXEZA	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022428-001	8450311	2029-05-29		Drug product	2013-06-10
N022428-001	9114168	2029-05-29		Drug product	2015-09-08

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	N022428-001	MOXEZA	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022428-001	MOXEZA	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022428-001	MOXEZA	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022428-001	MOXEZA	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022428-001	MOXEZA	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2	RLD, RS	2010-11-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022428-001	AT2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022428-001	AT2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022428-001	AT2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022428-001	AT2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022428-001	AT2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022428-001	AT2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022428-001	AT2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022428-001	AT2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022428-001	AT2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022428-001	AT2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022428-001	AT2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022428-001	AT2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022428-001	AT2	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022428-001	AT2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022428-001	AT2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022428-001	AT2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022428-001	AT2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022428-001	AT2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022428-001	AT2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022428-001	AT2	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022428-001	8450311	2029-05-29		Drug product	2013-06-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022428-001	9114168	2029-05-29		Drug product	2015-09-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022428-001	6716830	2019-09-29		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022428-001	7671070	2019-09-29	U-709	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022428-001	6716830*PED	2020-03-29		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022428-001	7671070*PED	2020-03-29		Pediatric extension		`74a2ff9319b5…`

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	American Health Packaging	1ed191f5-7df5-488c-bb72-91ac0b618d9a	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	bd0c0690-ba48-41c5-b76b-b1a53c36f424	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	Redpharm Drug	51d45346-5506-d2c9-e063-6394a90ae6bb	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	AvPAK	371ca7b2-c62d-ef4b-3076-890b385bfff8	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Mylan Institutional LLC	c6fa4129-2f92-4179-ac5d-bb7b4a538789	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	be5b7a6f-9ee3-4453-807e-4761fffff60c	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a98b20d-c4a1-4184-8387-a4866d1d62bf	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	18b77b31-baf3-416f-b3b7-a631c8e46d20	2026-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	6cd420c3-113e-4fc2-b59f-bfc7c485c14d	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
VIGAMOX	MOXIFLOXACIN HYDROCHLORIDE	Harrow Eye, LLC	12053b08-7e66-c6f3-e063-6394a90a9cd9	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Major Pharmaceuticals	815d71cf-02de-4190-9bd1-3fdc67ef0f06	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	ac8a81b9-2fed-412a-8c83-db8dee1061f6	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	f34c08e6-fe74-4de3-9e36-a82c3c1c183b	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	37466c79-8726-4fd6-9412-0bb83d523fe3	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin	MOXIFLOXACIN HYDROCHLORIDE	Solaris Pharma Corporation	45ce14e5-98b8-296b-e063-6294a90a769b	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Aurobindo Pharma Limited	d6789c17-4a2f-4519-9060-e3b0dba422f0	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	54377276-96bf-4140-9e90-55623ab6b013	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	Asclemed USA, Inc.	8f92f110-32d6-4d0c-a415-7a9a4cafb9b8	2025-04-19	Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	Somerset Therapeutics, LLC	f7c68d49-8c61-4bde-a880-4d78568e5aa0	2024-11-25	Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	02c29e8e-8346-4e28-b7fc-2f4cb61ad37d	2024-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0006	MOXEZA	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0006	MOXEZA	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0006	MOXEZA	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0006	MOXEZA	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68355	SUPPL	2021-08-12
68350	SUPPL	2021-08-12
47294	SUPPL	2017-02-23
47270	SUPPL	2017-02-21
38703	SUPPL	2012-09-18
7384	SUPPL	2012-09-18
29724	SUPPL	2011-10-20
24305	ORIG	2011-06-07
22020	ORIG	2011-06-07
38702	ORIG	2010-11-26
7383	ORIG	2010-11-26
53349	ORIG	1900-01-01
53348	ORIG	1900-01-01
53347	ORIG	1900-01-01