Application 021598

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIGAMOX	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
N021598-001	VIGAMOX	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021598-001	AT1

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	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021598-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021598-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021598-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021598-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021598-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021598-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021598-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021598-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021598-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021598-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021598-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021598-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021598-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021598-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021598-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021598-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021598-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021598-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021598-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021598-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021598-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021598-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021598-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021598-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021598-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021598-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021598-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021598-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021598-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021598-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021598-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021598-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021598-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021598-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021598-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021598-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021598-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021598-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021598-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021598-001	AT1	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021598-001	6716830	2019-09-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021598-001	7671070	2019-09-29	U-709		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021598-001	6716830	2019-09-29		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021598-001	7671070	2019-09-29	U-709		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021598-001	6716830	2019-09-29		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021598-001	7671070	2019-09-29	U-709		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021598-001	6716830	2019-09-29		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021598-001	7671070	2019-09-29	U-709		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VIGAMOX	MOXIFLOXACIN HYDROCHLORIDE	Harrow Eye, LLC	12053b08-7e66-c6f3-e063-6394a90a9cd9	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021598 application number: NDA021598
Moxifloxacin Ophthalmic Solution	MOXIFLOXACIN HYDROCHLORIDE	Sandoz Inc	fc88791b-24da-48a4-85f5-93a8af3d0b51	2020-06-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021598 application number: NDA021598 ndc (product): 0781-7135

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-4013	VIGAMOX	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-4013	VIGAMOX	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-4013	VIGAMOX	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-4013	VIGAMOX	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-4013	VIGAMOX	moxifloxacin hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0078-0939	VIGAMOX	moxifloxacin hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0939	VIGAMOX	moxifloxacin hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0781-7135	Moxifloxacin Ophthalmic Solution	moxifloxacin hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7135	Moxifloxacin Ophthalmic Solution	moxifloxacin hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7135	Moxifloxacin Ophthalmic Solution	moxifloxacin hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
21695-968	VIGAMOX	moxifloxacin hydrochloride	Rebel Distributors Corp	NDA	Current
50090-0859	VIGAMOX	moxifloxacin hydrochloride	A-S Medication Solutions	NDA	Current
50090-0859	VIGAMOX	moxifloxacin hydrochloride	A-S Medication Solutions	NDA	Current
70518-2043	VIGAMOX	moxifloxacin hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-2043	VIGAMOX	moxifloxacin hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63423	SUPPL	2020-06-05
63407	SUPPL	2020-06-03
62944	SUPPL	2020-05-13
62909	SUPPL	2020-05-12
47627	SUPPL	2017-03-21
47585	SUPPL	2017-03-20
37315	SUPPL	2011-10-12
5820	SUPPL	2011-10-12
42228	ORIG	2005-04-08
37314	SUPPL	2004-07-01
28225	SUPPL	2004-07-01
15854	SUPPL	2004-05-03
28224	SUPPL	2004-04-20
37313	SUPPL	2003-10-10
15853	SUPPL	2003-10-10
28223	SUPPL	2003-10-03
5819	SUPPL	2003-10-03
28222	ORIG	2003-05-29
15852	ORIG	2003-04-17
51389	ORIG	1900-01-01
51388	ORIG	1900-01-01