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NDA

METOPROLOL TARTRATE | N018704 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 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 Chain15 active DMFs15 inactive

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

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLMETOPROLOL TARTRATE

DMF 56051984

TAPI NL BVMETOPROLOL TARTRATE USP

DMF 68381987

TAPI NL BVMETOPROLOL TARTRATE

DMF 71511987

MOEHS IBERICA SLMETOPROLOL TARTRATE

DMF 73061988

IPCA LABORATORIES LTDMETOPROLOL TARTRATE USP

DMF 158502002

SUN PHARMACEUTICAL INDUSTRIES LTDMETOPROLOL TARTRATE USP

DMF 159952002

APITORIA PHARMA PRIVATE LTDMETOPROLOL TARTRATE USP

DMF 192832006

IPCA LABORATORIES LTDMETOPROLOL TARTRATE USP (PROCESS III)

DMF 212542008

CTX LIFE SCIENCES PVT LTDMETOPROLOL TARTRATE USP

DMF 213472008

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDMETOPROLOL TARTRATE

DMF 240382010

ALEMBIC PHARMACEUTICALS LTDMETOPROLOL TARTRATE USP

DMF 245262011

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDMETOPROLOL TARTRATE USP

DMF 288212014

MSN LIFE SCIENCES PRIVATE LTDMETOPROLOL TARTRATE USP

DMF 347052020

KOPRAN RESEARCH LABORATORIES LTDMETOPROLOL TARTRATE USP

DMF 349032020

ATUL BIOSCIENCE LTDMETOPROLOL TARTRATE USP

DMF 423122025

CAMBREX PROFARMACO MILANO SRLInactiveMETOPROLOL TARTRATE

DMF 48191982

ERREGIERRE SPAInactiveMETOPROLOL TARTRATE USP

DMF 62781986

CIPLA LTDInactiveMETOPROLOL TARTRATE

DMF 65991986

NEWPORT PHARMACEUTICALS IRELANDInactiveMETOPROLOL TARTRATE

DMF 81421989

RECORDATI INDUSTRIA CHIMICA SPAInactiveMETOPROLOL TARTRATE

DMF 88381990

SIEGFRIED AGInactiveMETOPROLOL TARTRATE

DMF 91101991

PLIVA CROATIA LTDInactiveMETOPROLOL TARTRATE

DMF 95391992

SYNCHEM CHEMICALS PVT LTDInactiveMETOPROLOL TARTRATE

DMF 98381992

FREEDOM CHEMICAL DIAMALT GMBHInactiveMETOPROLOL TARTRATE

DMF 98911992

SLOVAKOFARMA LTDInactiveMETOPROLOL TARTRATE

DMF 116301995

COSMA SPAInactiveMETOPROLOL TARTRATE

DMF 143241999

MOEHS IBERICA SLInactiveMETOPROLOL TARTRATE USP

DMF 149072000

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveMETOPROLOL TARTRATE USP

DMF 218652008

POLYDRUG LABORATORIES PVT LTDInactiveMETOPROLOL TARTRATE USP

DMF 219412008

CTX LIFE SCIENCES PVT LTDInactiveMETOPROLOL TARTRATE USP (ROUTE-I)

DMF 229362009

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Aug 25, 2020	SUPPL -28	View Letter (PDF)
Aug 25, 2020	SUPPL -27	View Letter (PDF)
Mar 15, 2013	SUPPL -26	View Letter (PDF)
Dec 26, 2012	SUPPL -25	View Letter (PDF)
Jan 6, 2010	SUPPL -23	View Letter (PDF)
Jul 30, 2008	SUPPL -21	View Letter (PDF)
Jan 9, 2008	SUPPL -20	View Letter (PDF)
Sep 18, 2006	SUPPL -18	View Letter (PDF)
Sep 25, 2003	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 30, 1984

No patent or exclusivity listings for this strength.