Application 202916

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% BASE	No	No

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
A202916-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC			2017-11-09

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`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	A202916-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202916-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202916-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202916-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202916-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202916-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202916-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202916-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202916-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202916-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202916-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202916-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202916-001	AT1	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A202916-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202916-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202916-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202916-001	AT1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202916-001	AT1	1	`cb3db0bc1861…`

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
MOXIFLOXACIN	MOXIFLOXACIN	Direct Rx	d9b6a460-6377-76d0-e053-2995a90a3d05	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202916 application number: ANDA202916 ndc (product): 72189-334

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-519	Moxifloxacin	Moxifloxacin	Akorn, Inc.	ANDA	Current
17478-519	Moxifloxacin	Moxifloxacin	Akorn	ANDA	Current
17478-519	Moxifloxacin	Moxifloxacin	Akorn, Inc.	ANDA	Current
50090-5279	Moxifloxacin	Moxifloxacin	A-S Medication Solutions	ANDA	Current
55700-657	Moxifloxacin	Moxifloxacin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
72189-334	MOXIFLOXACIN	MOXIFLOXACIN	Direct Rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10135	ORIG	2013-11-20