Application 202801

Type: ANDA
Sponsor: HETERO LABS LTD V

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 44.

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
A202801-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08
A202801-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08
A202801-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202801-001	AB
A202801-002	AB
A202801-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A202801-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202801-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202801-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202801-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202801-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202801-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202801-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202801-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202801-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202801-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202801-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202801-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202801-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202801-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202801-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202801-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202801-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202801-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202801-001	AB	1	`79d66fd596c7…`

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	54a02488-586d-4c4e-8a35-68a067bdd6e3	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801 ndc (product): 71335-0593
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	804ec547-5b89-4fd0-89b3-7445543e563e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801 ndc (product): 71335-0434
Levofloxacin	LEVOFLOXACIN	Camber Pharmaceuticals, Inc.	b43e9b51-568c-4d84-bbd1-d237120056c4	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals, Inc.	4a405103-41e8-6a1f-e054-00144ff8d46c	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	631523e7-7d67-0cc3-e053-2a91aa0abb62	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	72cb9372-e9f8-3ca1-e053-2a91aa0ad820	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	95149cfb-1a71-42b7-b50d-9a2e94334339	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 117 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70934-094	Levofloxacin	Levofloxacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-094	Levofloxacin	Levofloxacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-094	Levofloxacin	Levofloxacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-094	Levofloxacin	Levofloxacin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-094	Levofloxacin	Levofloxacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-641	Levofloxacin	Levofloxacin	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-002	Levofloxacin	Levofloxacin	Proficient Rx LP	ANDA	Current
71205-002	Levofloxacin	Levofloxacin	Proficient Rx LP	ANDA	Current
71205-002	Levofloxacin	Levofloxacin	Proficient Rx LP	ANDA	Current
71205-002	Levofloxacin	Levofloxacin	Proficient Rx LP	ANDA	Current
71205-002	Levofloxacin	Levofloxacin	Proficient Rx LP	ANDA	Current
71335-0434	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0434	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0434	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0434	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0593	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0593	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0593	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0593	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0794	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0794	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0794	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
71335-0794	Levofloxacin	Levofloxacin	Bryant Ranch Prepack	ANDA	Current
72189-338	Levofloxacin	Levofloxacin	DirectRx	ANDA	Current
72189-338	Levofloxacin	Levofloxacin	DirectRx	ANDA	Current
72789-248	Levofloxacin	Levofloxacin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-248	Levofloxacin	Levofloxacin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-248	Levofloxacin	Levofloxacin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
80425-0007	Levaquin	Levofloxacin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0007	Levaquin	Levofloxacin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0007	Levofloxacin	Levofloxacin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0007	Levofloxacin	Levofloxacin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0007	Levofloxacin	Levofloxacin	ADVANCED RX PHARMACY OF TENNESSEE, LLC	ANDA	Current
80425-0077	Levaquin	Levofloxacin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0077	Levofloxacin	Levofloxacin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0077	Levofloxacin	Levofloxacin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0077	Levofloxacin	Levofloxacin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10111	ORIG	2015-01-12