Application 200250

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	250MG	No	No
002	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	500MG	No	No
003	LEVOFLOXACIN	LEVOFLOXACIN	TABLET;ORAL	750MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200250-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20
A200250-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20
A200250-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200250-001	AB
A200250-002	AB
A200250-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200250-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200250-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200250-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200250-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200250-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200250-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200250-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200250-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200250-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200250-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200250-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200250-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200250-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200250-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200250-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200250-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200250-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200250-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200250-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200250-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200250-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200250-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200250-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200250-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200250-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200250-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200250-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200250-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200250-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200250-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200250-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200250-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200250-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200250-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200250-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200250-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200250-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200250-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200250-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200250-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200250-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200250-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200250-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	Sagent Pharmaceuticals	699fbdb8-a6fd-476a-9b80-08197d869534	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	HAWAII REPACK, INC.	857f256c-88ac-4f73-9815-c2724edf2f1e	2026-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	2a4e97e0-0709-411b-92e8-6f7d669412e4	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	710c0c10-89a5-4954-8f74-acc187c5cf0f	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Chartwell RX, LLC	5c6c117c-9d91-48f4-9aaa-ee70b99218c2	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	f14cf651-a213-4a4f-adb9-f628562af27c	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Redpharm Drug	5261da15-1b6c-fbe2-e063-6394a90ad85e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Cardinal Health 107, LLC	070375be-3b67-4299-ae8f-4a7b157ac16f	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals, Inc.	bcad1dad-53aa-43dd-90f3-cc17cc9598d5	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals, Inc.	2a8676a9-247f-4fdb-b644-e9785d98771f	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	9f944b63-9b60-437a-ba57-d14d7976bc32	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
LEVOFLOXACIN	LEVOFLOXACIN	DIRECT RX	4f40d5fa-ebcc-516c-e054-00144ff8d46c	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOFLOXACIN generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	a5ae33ad-4703-4cb2-8618-6439c906be99	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Redpharm Drug	44f31105-5fc9-43d4-e063-6294a90a510f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	264a3f71-f23e-45e3-926a-421bcccf4e3d	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc.	7a12135e-cbad-4fe1-98f7-53c41d1f2a21	2026-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	b8ac5047-5203-42c4-886b-dd0b08a1786f	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	16d51c1c-4144-4be7-9356-98fcee621ecd	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f2f090c2-3ee1-7689-e053-2995a90abe38	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f780bb91-483a-d1a6-e053-6294a90ab74b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levofloxacin generic name: LEVOFLOXACIN

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
68462-326	Levofloxacin	Levofloxacin	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-327	Levofloxacin	Levofloxacin	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-328	Levofloxacin	Levofloxacin	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current