Application 076089

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPROFLOXACIN	CIPROFLOXACIN	TABLET; ORAL	100MG	No	No
002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	TABLET;ORAL	EQ 250MG BASE	No	No
003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	TABLET;ORAL	EQ 500MG BASE	No	No
004	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	TABLET;ORAL	EQ 750MG BASE	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
A076089-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09
A076089-003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09
A076089-004	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076089-002	AB
A076089-003	AB
A076089-004	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	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076089-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076089-004	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	AB	2004-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076089-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	AB	2004-06-09	`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	A076089-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076089-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076089-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076089-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076089-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076089-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076089-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076089-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076089-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076089-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076089-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076089-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076089-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076089-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076089-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076089-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076089-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076089-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076089-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076089-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076089-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076089-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076089-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076089-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076089-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076089-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076089-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076089-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076089-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076089-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076089-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076089-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076089-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076089-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076089-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076089-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076089-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076089-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076089-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076089-002	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 8 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	df24efa3-c9a0-4f40-92ce-cc71c708931b	2018-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4e74496f-4dca-4471-be32-c0a14bc62750	2018-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin
Ciprofloxacin	CIPROFLOXACIN	Aphena Pharma Solutions - Tennessee, LLC	c7bc0d20-526c-48ea-b23a-cea9eb7080ff	2018-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin generic name: CIPROFLOXACIN

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 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0172-5312	Ciprofloxacin	Ciprofloxacin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
10544-606	Ciprofloxacin hydrochloride	Ciprofloxacin hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
53808-0223	Ciprofloxacin hydrochloride	Ciprofloxacin hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
66116-508	Ciprofloxacin Hydrochloride	Ciprofloxacin Hydrochloride	MedVantx, Inc.	ANDA	Current
67296-0543	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride tablet	RedPharm Drug Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31073	ORIG	2004-06-15