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CHLORAPREP ONE-STEP

NDA

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | N020832 | BECTON DICKINSON AND CO

8 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

2027

Today

7422388

Apr. 25, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Apr 5, 2019	SUPPL -36	View Letter (PDF)
Sep 19, 2017	SUPPL -42	View Letter (PDF)
Jul 1, 2014	SUPPL -34	View Letter (PDF)
Oct 11, 2013	SUPPL -31	View Letter (PDF)
Jan 10, 2013	SUPPL -29	View Letter (PDF)
Aug 17, 2012	SUPPL -30	View Letter (PDF)
Aug 17, 2012	SUPPL -28	View Letter (PDF)
Aug 17, 2012	SUPPL -27	View Letter (PDF)
Jul 23, 2010	SUPPL -26	View Letter (PDF)
Mar 8, 2010	SUPPL -25	View Letter (PDF)
Oct 24, 2008	SUPPL -22	View Letter (PDF)
Jun 6, 2008	SUPPL -14	View Letter (PDF)
May 16, 2007	SUPPL -18	View Letter (PDF)
Dec 28, 2006	SUPPL -12	View Letter (PDF)
Dec 4, 2006	SUPPL -15	View Letter (PDF)
Oct 18, 2006	SUPPL -16	View Letter (PDF)
Oct 18, 2006	SUPPL -13	View Letter (PDF)
Apr 7, 2006	SUPPL -10	View Letter (PDF)
Jan 6, 2006	SUPPL -11	View Letter (PDF)
May 4, 2005	SUPPL -8	View Letter (PDF)
Jul 7, 2004	SUPPL -7	View Letter (PDF)
Jun 15, 2004	SUPPL -6	View Letter (PDF)
Aug 28, 2003	SUPPL -4	View Letter (PDF)
Apr 26, 2002	SUPPL -2	View Letter (PDF)
Jul 14, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#001 — 2%;70% (3ML)

RLD

0 patents0 exclusivities▴

SPONGE;TOPICAL | Approved: Jul 14, 2000

No patent or exclusivity listings for this strength.

#004 — 2%;70% (10.5ML)

RLD

0 patents0 exclusivities▾

SPONGE;TOPICAL | Approved: Aug 20, 2003

#006 — 2%;70% (26ML)

RLD

0 patents0 exclusivities▾

SPONGE;TOPICAL | Approved: Nov 21, 2006

#008 — 2%;70% (1ML)

RLD

0 patents0 exclusivities▾

SPONGE;TOPICAL | Approved: Oct 23, 2008

#003 — 2%;70% (1.5ML)

RLD

0 patents0 exclusivities▾

SPONGE;TOPICAL | Approved: Apr 26, 2002

#002 — 2%;70% (26ML)

RLD

1 patent0 exclusivities▾

SPONGE;TOPICAL | Approved: May 3, 2005

#005 — 2%;70% (10.5ML)

RLD

1 patent0 exclusivities▾

SPONGE;TOPICAL | Approved: Apr 3, 2006

#007 — 2%;70% (3ML)

RLD

1 patent0 exclusivities▾

SPONGE;TOPICAL | Approved: Oct 10, 2006