Application 021473

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPRO XR	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	CIPRO XR	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021473-001	CIPRO XR	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL			2002-12-13
N021473-002	CIPRO XR	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL			2003-08-28

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021473-001	7709022	2021-06-23	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	7709022	2021-06-23	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	8187632	2021-06-23	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021473-001	7709022	2021-06-23	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-002	7709022	2021-06-23	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-002	8187632	2021-06-23	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-001	7709022	2021-06-23	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-002	7709022	2021-06-23	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-002	8187632	2021-06-23	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021473-001	7709022	2021-06-23	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-002	7709022	2021-06-23	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-002	8187632	2021-06-23	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021473-001	7709022	2021-06-23	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-002	7709022	2021-06-23	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-002	8187632	2021-06-23	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`8869cabd3fbd…`

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-788	Cipro	ciprofloxacin	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-789	Cipro	ciprofloxacin	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66951	SUPPL	2021-04-01
66950	SUPPL	2021-04-01
66928	SUPPL	2021-03-31
62906	SUPPL	2020-05-11
62905	SUPPL	2020-05-11
62886	SUPPL	2020-05-11
62084	SUPPL	2020-03-09
62063	SUPPL	2020-03-06
62062	SUPPL	2020-03-06
58626	SUPPL	2019-05-08
58595	SUPPL	2019-05-07
56070	SUPPL	2018-10-23
56024	SUPPL	2018-10-19
49109	SUPPL	2017-07-28
49089	SUPPL	2017-07-27
15554	SUPPL	2016-07-26
5479	SUPPL	2016-07-26
24001	ORIG	2016-02-03
37026	SUPPL	2015-02-03
27893	SUPPL	2015-02-02
27892	SUPPL	2013-08-16
15553	SUPPL	2013-08-15
37025	SUPPL	2013-02-01
5478	SUPPL	2013-01-31
5476	SUPPL	2011-11-21
15552	SUPPL	2011-11-16
37024	SUPPL	2011-11-04
27891	SUPPL	2011-10-20
5477	SUPPL	2011-08-08
27890	SUPPL	2011-06-15
37023	SUPPL	2011-06-14
37022	SUPPL	2011-03-04
27889	SUPPL	2011-03-02
27888	SUPPL	2009-06-30
15551	SUPPL	2009-05-11
5475	SUPPL	2009-05-07
15550	SUPPL	2008-10-09
5474	SUPPL	2008-10-07
37021	SUPPL	2008-01-23
5473	SUPPL	2008-01-23
42186	SUPPL	2007-07-09
21681	SUPPL	2007-07-09
21680	SUPPL	2007-07-09
21679	SUPPL	2007-07-09
21678	SUPPL	2007-07-09
5472	SUPPL	2007-07-05
37020	SUPPL	2007-06-27
27887	SUPPL	2005-11-18
37019	SUPPL	2005-11-17
37018	SUPPL	2005-05-20
27886	SUPPL	2005-05-20
37017	SUPPL	2004-07-21
37016	SUPPL	2004-07-21
27885	SUPPL	2004-07-21
27884	SUPPL	2004-07-21
15549	SUPPL	2004-07-21
5471	SUPPL	2004-07-21
42185	ORIG	2003-11-06
15548	ORIG	2002-12-16
5470	ORIG	2002-12-13