Viewing data from:

CHILDREN'S CLARITIN

NDA

LORATADINE | N021891 | 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

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

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

23 letters from Drugs@FDA

Date	Submission	Document
May 21, 2026	SUPPL -47	View Letter (PDF)
Apr 27, 2026	SUPPL -45	View Letter (PDF)
Apr 28, 2025	SUPPL -46	View Letter (PDF)
Sep 23, 2024	SUPPL -44	View Letter (PDF)
Dec 28, 2022	SUPPL -43	View Letter (PDF)
Apr 6, 2021	SUPPL -38	View Letter (PDF)
Jan 8, 2021	SUPPL -36	View Letter (PDF)
Aug 10, 2020	SUPPL -34	View Letter (PDF)
Dec 11, 2019	SUPPL -32	View Letter (PDF)
Oct 7, 2019	SUPPL -33	View Letter (PDF)
Jun 18, 2019	SUPPL -31	View Letter (PDF)
Jan 4, 2019	SUPPL -28	View Letter (PDF)
Dec 12, 2018	SUPPL -29	View Letter (PDF)
Jul 23, 2018	SUPPL -27	View Letter (PDF)
Feb 23, 2018	SUPPL -26	View Letter (PDF)
May 25, 2017	SUPPL -23	View Letter (PDF)
Apr 7, 2016	SUPPL -21	View Letter (PDF)
Dec 29, 2015	SUPPL -20	View Letter (PDF)
Jul 28, 2014	SUPPL -18	View Letter (PDF)
Jun 29, 2010	SUPPL -8	View Letter (PDF)
Oct 23, 2008	SUPPL -4	View Letter (PDF)
Oct 9, 2008	SUPPL -5	View Letter (PDF)
Sep 18, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLD

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Aug 23, 2006

No patent or exclusivity listings for this strength.

#002 — 10MG

RLD

0 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Nov 21, 2018