Application 077098

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OFLOXACIN	OFLOXACIN	TABLET;ORAL	200MG	No	No
002	OFLOXACIN	OFLOXACIN	TABLET;ORAL	300MG	No	No
003	OFLOXACIN	OFLOXACIN	TABLET;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077098-001	OFLOXACIN	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10
A077098-002	OFLOXACIN	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10
A077098-003	OFLOXACIN	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077098-001	AB
A077098-002	AB
A077098-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077098-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077098-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077098-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077098-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077098-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077098-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077098-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077098-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077098-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077098-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077098-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077098-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077098-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077098-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077098-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077098-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077098-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077098-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077098-001	AB	1	`301d65b070ca…`

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 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin Otic	OFLOXACIN	REMEDYREPACK INC.	42366170-e536-46a1-9735-d76e5820a9de	2026-08-31	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	REMEDYREPACK INC.	50bca624-4dc0-4d1b-a693-2eb602eaf2f2	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
ofloxacin	OFLOXACIN OTIC	REMEDYREPACK INC.	fe619d50-49bf-4fcc-9428-6108c45580eb	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
Ofloxacin	OFLOXACIN	REMEDYREPACK INC.	38d0bbce-58ca-4fc1-a887-87b61fef9a87	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	NorthStar RxLLC	b95114f6-6753-4217-b621-44fa34afc298	2026-08-13	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
ofloxacin	OFLOXACIN OTIC	Lifestar Pharma LLC	0621700e-6315-47ff-a8ed-cccf7d6fc56a	2026-08-13	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals, Inc.	0c01de7a-a885-4bf0-8df0-7c62170b7850	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	306ed758-3c43-4f42-bd44-562ec65891dc	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN OTIC	Sportpharm LLC	3f5972db-4eaf-4237-944d-8f63eff7b9b1	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: ofloxacin
Ofloxacin	OFLOXACIN	St. Mary's Medical Park Pharmacy	2d55b26d-9d12-ca29-e063-6294a90ab237	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
OFLOXACIN	OFLOXACIN	Modavar Pharmaceuticals LLC	93ed9f70-b44f-496b-bdfc-c1bd5f1c260b	2026-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OFLOXACIN generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	ST. MARY'S MEDICAL PARK PHARMACY	27c247e5-ef93-e9a5-e063-6394a90a2e1e	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
ofloxacin	OFLOXACIN	REMEDYREPACK INC.	d97651cc-d9ea-4be4-8ea1-3d0278582dd5	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: ofloxacin generic name: OFLOXACIN
OFLOXACIN OTIC	OFLOXACIN	DIRECT RX	a7952956-b64a-0f99-e053-2995a90a0f91	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	5f4213e4-de32-4c03-8800-e254b98538ea	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	A-S Medication Solutions	537c6351-c7f1-47c9-95de-011bac850768	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	f7916bb3-7593-45f8-b9de-98e0f2d57227	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Rising Pharma Holdings, Inc.	c76d8dc7-9a66-471b-814b-ef7f3605ec93	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Rising Pharma Holdings, Inc.	2e912ed6-51e8-40c3-bf10-2af092c63be8	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN
Ofloxacin	OFLOXACIN	Redpharm Drug	2fbd51a5-462c-4741-e063-6394a90a0d87	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Ofloxacin generic name: OFLOXACIN

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
55111-160	Ofloxacin	ofloxacin	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-161	Ofloxacin	ofloxacin	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-162	Ofloxacin	ofloxacin	Dr. Reddy's Laboratories Limited	ANDA	Current