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CLARITIN

NDA

LORATADINE | N020641 | BAYER HEALTHCARE LLC

2 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain12 active DMFs12 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

QUIMICA SINTETICA SALORATADINE

DMF 118031995

MOREPEN LABORATORIES LTDLORATADINE

DMF 126501997

ROLABO OUTSOURCING SLLORATADINE USP

DMF 141551999

SUN PHARMACEUTICAL INDUSTRIES LTDLORATADINE USP

DMF 152512001

CADILA PHARMACEUTICALS LTDLORATADINE USP POWDER

DMF 175822004

ZYDUS LIFESCIENCES LTDLORATADINE USP

DMF 187022005

ALIVUS LIFE SCIENCES LTDLORATADINE USP

DMF 194002006

VASUDHA PHARMA CHEM LTDLORATADINE USP

DMF 203672007

MATRIX PHARMACORP PRIVATE LTDLORATADINE USP (LCP)

DMF 204472007

MOREPEN LABORATORIES LTDLORATADINE (PROCESS 2) U.S.P.

DMF 206692007

SOLARA ACTIVE PHARMA SCIENCES LTDLORATADINE USP

DMF 284112014

VASUDHA PHARMA CHEM LTDLORATADINE USP (PROCESS-II)

DMF 348222020

MSD INTERNATIONAL GMBHInactiveLORATADINE

DMF 66261986

QUIMICA SINTETICA SAInactiveLORATADINE

DMF 98301992

MSD INTERNATIONAL GMBHInactiveLORATADINE

DMF 130321998

INKE SAInactiveLORATADINE

DMF 138111998

MEDICHEM SAInactiveLORATADINE

DMF 138421998

CADILA HEALTHCARE LTDInactiveLORATADINE

DMF 169702003

MYLAN LABORATORIES LTDInactiveLORATADINE USP (LDP)

DMF 172872004

DIVIS LABORATORIES LTDInactiveLORATADINE USP

DMF 178102004

SUZHOU WANQING PHARMACEUTICALS CO LTDInactiveLORATADINE

DMF 180582005

CATALENT PHARMA SOLUTIONS LLCInactiveLORATADINE SOFTGELS (10 MG)

DMF 186962005

ZHEJIANG WEPON PHARMACEUTICAL CO LTDInactiveLORATADINE

DMF 197402006

AARTI DRUGS LTDInactiveLORATADINE

DMF 204962007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Dec 16, 2024	SUPPL -48	View Letter (PDF)
Mar 1, 2019	SUPPL -46	View Letter (PDF)
May 16, 2018	SUPPL -45	View Letter (PDF)
Aug 9, 2016	SUPPL -42	View Letter (PDF)
Dec 31, 2015	SUPPL -40	View Letter (PDF)
Nov 9, 2015	SUPPL -38	View Letter (PDF)
Oct 23, 2015	SUPPL -37	View Letter (PDF)
Apr 22, 2015	SUPPL -36	View Letter (PDF)
Mar 1, 2013	SUPPL -32	View Letter (PDF)
Jul 30, 2008	SUPPL -24	View Letter (PDF)
Jul 30, 2008	SUPPL -25	View Letter (PDF)
Jun 15, 2005	SUPPL -18	View Letter (PDF)
Oct 29, 2004	SUPPL -17	View Letter (PDF)
Jul 21, 2004	SUPPL -16	View Letter (PDF)
Nov 25, 2003	SUPPL -11	View Letter (PDF)
Nov 27, 2002	SUPPL -9	View Letter (PDF)
Dec 4, 2000	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 1MG/ML

RLD

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Nov 27, 2002

No patent or exclusivity listings for this strength.

#003 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SYRUP;ORAL | Approved: Nov 19, 2003