Application 209469

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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
A209469-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2019-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209469-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209469-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2019-02-13	`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	A209469-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209469-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209469-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209469-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209469-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209469-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209469-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209469-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209469-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209469-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209469-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209469-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209469-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209469-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209469-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209469-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209469-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209469-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209469-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209469-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209469-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209469-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209469-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209469-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209469-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209469-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209469-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209469-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209469-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209469-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209469-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209469-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209469-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209469-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209469-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209469-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209469-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209469-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209469-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209469-001	AT1	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin ophthalmic solution	MOXIFLOXACIN OPHTHALMIC SOLUTION	Alembic Pharmaceuticals Limited	fee8323d-bcb0-4f49-a06d-2ed597a7b2ac	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209469 application number: ANDA209469
Moxifloxacin ophthalmic solution	MOXIFLOXACIN OPHTHALMIC SOLUTION	Alembic Pharmaceuticals Inc.	0f2cdbf6-bc74-4b22-b795-23ace89894b3	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209469 application number: ANDA209469 ndc (product): 62332-505
Moxifloxacin ophthalmic solution	MOXIFLOXACIN OPHTHALMIC	A-S Medication Solutions	e33b3315-54f6-47ce-8a4f-3b79be408540	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209469 application number: ANDA209469 ndc (product): 50090-4781

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4781	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic	A-S Medication Solutions	ANDA	Current
50090-4781	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic	A-S Medication Solutions	ANDA	Current
50090-4781	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic	A-S Medication Solutions	ANDA	Current
53002-2626	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic	RPK Pharmaceuticals, Inc.	ANDA	Current
62332-505	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic solution	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-505	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic solution	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-505	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic solution	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-505	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic solution	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-505	Moxifloxacin ophthalmic solution	Moxifloxacin ophthalmic solution	Alembic Pharmaceuticals Inc.	ANDA	Current