Application 076938

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	TABLET;ORAL	EQ 400MG 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
A076938-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076938-001	AB

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	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2014-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2014-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2014-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`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	A076938-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076938-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076938-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076938-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076938-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076938-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076938-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076938-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076938-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076938-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076938-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076938-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076938-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076938-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076938-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076938-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076938-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076938-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076938-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076938-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076938-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076938-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076938-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076938-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076938-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076938-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076938-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076938-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076938-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076938-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076938-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076938-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076938-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076938-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076938-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076938-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076938-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076938-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076938-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076938-001	AB	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	MOXIFLOXACIN	PD-Rx Pharmaceuticals, Inc.	1c6f7150-a8f4-408f-956f-c26d37030cf4	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076938 application number: ANDA076938 ndc (product): 72789-233
Moxifloxacin	MOXIFLOXACIN	Bryant Ranch Prepack	d20ba997-30de-445c-8766-924112bd834a	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076938 application number: ANDA076938 ndc (product): 63629-8357
Moxifloxacin	MOXIFLOXACIN	Dr. Reddy's Laboratories Limited	71b02da1-3175-1db8-192a-c0a8a6cd98a5	2020-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076938 application number: ANDA076938 ndc (product): 55111-112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6406	Moxifloxacin	Moxifloxacin	Major Pharmaceuticals	ANDA	Current
0904-6406	Moxifloxacin	Moxifloxacin	Major Pharmaceuticals	ANDA	Current
0904-6406	Moxifloxacin	Moxifloxacin	Major Pharmaceuticals	ANDA	Current
50090-3147	Moxifloxacin	Moxifloxacin	A-S Medication Solutions	ANDA	Current
50090-3147	Moxifloxacin	Moxifloxacin	A-S Medication Solutions	ANDA	Current
55111-112	Moxifloxacin	Moxifloxacin	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-112	Moxifloxacin	Moxifloxacin	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-112	Moxifloxacin	Moxifloxacin	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-112	Moxifloxacin	Moxifloxacin	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-112	Moxifloxacin	Moxifloxacin	Dr. Reddy's Laboratories Limited	ANDA	Current
55700-638	Moxifloxacin	Moxifloxacin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63629-8357	Moxifloxacin	Moxifloxacin	Bryant Ranch Prepack	ANDA	Current
63629-8357	Moxifloxacin	Moxifloxacin	Bryant Ranch Prepack	ANDA	Current
63629-8357	Moxifloxacin	Moxifloxacin	Bryant Ranch Prepack	ANDA	Current
63629-8357	Moxifloxacin	Moxifloxacin	Bryant Ranch Prepack	ANDA	Current
67296-1679	Moxifloxacin	Moxifloxacin	RedPharm Drug, Inc.	ANDA	Current
67296-1679	Moxifloxacin	Moxifloxacin	RedPharm Drug, Inc.	ANDA	Current
72789-233	Moxifloxacin	Moxifloxacin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-233	Moxifloxacin	Moxifloxacin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8982	ORIG	2014-03-06