Home Applications 019537 Application 019537
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CIPRO CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 CIPRO CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 250MG BASE Yes No 003 CIPRO CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 500MG BASE Yes Yes 004 CIPRO CIPROFLOXACIN HYDROCHLORIDE TABLET;ORAL EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 RLD / RS Approval date N019537-002 CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 N019537-003 CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 N019537-004 CIPRO CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 156 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019537-001 CIPRO EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019537-004 CIPRO EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1987-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019537-001 CIPRO EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019537-002 CIPRO EQ 250MG BASE TABLET / ORAL AB RLD 1987-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019537-003 CIPRO EQ 500MG BASE TABLET / ORAL AB RLD, RS 1987-10-22 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cipro CIPROFLOXACIN HYDROCHLORIDE Bayer HealthCare Pharmaceuticals Inc. 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0 2026-03-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019537 application number: NDA019537 ndc (product): 50419-758 ndc (product): 50419-754
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-754 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-758 Cipro ciprofloxacin hydrochloride Bayer HealthCare Pharmaceuticals Inc. NDA Current