Home Applications 020780 Application 020780
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CIPRO CIPROFLOXACIN FOR SUSPENSION;ORAL 250MG/5ML Yes No 002 CIPRO CIPROFLOXACIN FOR SUSPENSION;ORAL 500MG/5ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020780-001 CIPRO CIPROFLOXACIN 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 N020780-002 CIPRO CIPROFLOXACIN 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26
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 3 · 84 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 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL RLD 1997-09-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL RLD, RS 1997-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL RLD 1997-09-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL RLD, RS 1997-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL RLD 1997-09-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL RLD, RS 1997-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL AB RLD 1997-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL AB RLD, RS 1997-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020780-001 CIPRO 250MG/5ML FOR SUSPENSION / ORAL RLD 1997-09-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020780-002 CIPRO 500MG/5ML FOR SUSPENSION / ORAL RLD, RS 1997-09-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 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): 020780 application number: NDA020780 ndc (product): 50419-773 ndc (product): 50419-777
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 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-773 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-777 Cipro ciprofloxacin Bayer HealthCare Pharmaceuticals Inc. NDA Current