Application 205833

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	MOXIFLOXACIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	400MG/250ML (1.6MG/ML)	No	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
A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	MOXIFLOXACIN HYDROCHLORIDE	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS		RS	2017-05-05

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205833-001	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	400MG/250ML (1.6MG/ML)	SOLUTION / INTRAVENOUS	RS	2017-05-05	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Mylan Institutional LLC	c6fa4129-2f92-4179-ac5d-bb7b4a538789	2026-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205833 application number: ANDA205833 ndc (product): 67457-323

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-323	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Mylan Institutional LLC	ANDA	Current
67457-323	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Mylan Institutional LLC	ANDA	Current
67457-323	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Mylan Institutional LLC	ANDA	Current