Application 076136

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	TABLET;ORAL	EQ 250MG BASE	No	No
002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	TABLET;ORAL	EQ 500MG BASE	No	No
003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	TABLET;ORAL	EQ 750MG BASE	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	Approval date
A076136-001	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09
A076136-002	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09
A076136-003	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076136-001	CIPROFLOXACIN HYDROCHLORIDE	EQ 250MG BASE	TABLET / ORAL	2004-06-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076136-002	CIPROFLOXACIN HYDROCHLORIDE	EQ 500MG BASE	TABLET / ORAL	2004-06-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076136-003	CIPROFLOXACIN HYDROCHLORIDE	EQ 750MG BASE	TABLET / ORAL	2004-06-09	`3a93d1ddd44b…`

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 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	47d1e4c5-f669-4aca-9e8c-0d6bb833b859	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Coupler LLC	58388197-82f4-0953-e063-6294a90ac52a	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin Hydrochloride generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Proficient Rx LP	b281a5c0-5f3e-4e6f-86ac-ed7794aac64c	2026-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin Hydrochloride generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Redpharm Drug	57e5832f-9168-1f24-e063-6294a90aaae6	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc	b7ac7e18-fd34-44df-8a0e-87dafbc7a2f5	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin Hydrochloride generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	HAWAII REPACK, INC.	0fe3becb-f90e-4187-a8e8-bd0de5a79ad2	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a2ffa81a-86c5-40b9-8fa0-c889801ef479	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a914512b-9a4a-4c53-ab7a-2e2b1ea8a012	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Aurobindo Pharma Limited	6a935846-3c97-4517-bc4e-2377f673285e	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Redpharm Drug	1ac4540c-d0f7-70bc-e063-6394a90a0f7a	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin Hydrochloride generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	d8b21832-b74f-4f85-a304-b907c9e01e72	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	9d83b127-ef13-4b2c-aa30-0f54937dc240	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	American Health Packaging	275de35b-5c97-4ff8-a571-42e23c1cd83e	2026-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	Asclemed USA, Inc.	ae77a5c0-a2ae-770c-e053-2a95a90a6a96	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	26e2d370-f59c-40ae-9c1e-7f8bf1f9fde4	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin	CIPROFLOXACIN HYDROCHLORIDE	American Health Packaging	0fac4466-fbe5-49d2-96e3-e3ac2739bd5b	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	78641acd-eedf-4b68-bb18-da0874415f59	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin Hydrochloride generic name: CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN	CIPROFLOXACIN HYDROCHLORIDE	DIRECT RX	a7e5174a-dd01-6050-e053-2a95a90add3f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Cipro	CIPROFLOXACIN HYDROCHLORIDE	Bayer HealthCare Pharmaceuticals Inc.	888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride	CIPROFLOXACIN HYDROCHLORIDE	Redpharm Drug	4972e902-e042-e947-e063-6394a90a1b70	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ciprofloxacin Hydrochloride generic name: CIPROFLOXACIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31086	ORIG	2004-06-15
31085	ORIG	2003-04-16