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SEREVENT

NDA

SALMETEROL XINAFOATE | N020692 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND

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 Chain12 active DMFs9 inactive

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

NATCO PHARMA LTDSALMETEROL XINAFOATE

DMF 183942005

AARTI PHARMALABS LTDSALMETEROL XINAFOATE

DMF 220542008

NEULAND LABORATORIES LTDSALMETEROL XINAFOATE USP

DMF 229732009

INKE SASALMETEROL XINAFOATE

DMF 239142010

GLAXOSMITHKLINE LLCSALMETEROL XINAFOATE

DMF 245822011

GANGWAL HEALTHCARE PRIVATE LTDSALMETEROL XINAFOATE IP/BP

DMF 268632013

MELODY HEALTHCARE PVT LTDSALMETEROL XINAFOATE USP

DMF 303872016

MSN LABORATORIES PRIVATE LTDSALMETEROL XINAFOATE USP

DMF 312422016

HOVIONE FARMACIENCIA SASALMETEROL XINAFOATE INHALATION GRADE

DMF 317952017

HOVIONE PHARMASCIENCE LTDSALMETEROL XINAFOATE MICRONIZED

DMF 327852018

CIPLA LTDSALMETEROL XINAFOATE USP

DMF 343352019

PORTON PHARMA SOLUTIONS LTDSALMETEROL XINAFOATE API

DMF 370702022

CIPLA LTDInactiveSALMETEROL XINAFOATE

DMF 157062001

CIPLA LTDInactiveSALMETEROL XINAFOATE

DMF 183782005

MYLAN LABORATORIES LTDInactiveSALMETEROL XINAFOATE USP

DMF 218592008

DR REDDYS LABORATORIES LTDInactiveSALMETEROL XINAFOATE

DMF 225862009

MELODY HEALTHCARE PVT LTDInactiveSALMETEROL XINAFOATE

DMF 240402010

MSN LABORATORIES PRIVATE LTDInactiveSALMETEROL XINAFOATE USP [ROUTE CODE - SX]

DMF 248282011

CADILA HEALTHCARE LTDInactiveSALMETEROL XINAFOATE USP

DMF 256462012

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDInactiveSALMETEROL XINAFOATE

DMF 286992014

VAMSI LABS LTDInactiveSALMETEROL XINAFOATE EP

DMF 402842024

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

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Jul 23, 2019	SUPPL -47	View Letter (PDF)
Dec 31, 2018	SUPPL -46	View Letter (PDF)
Oct 5, 2016	SUPPL -45	View Letter (PDF)
Apr 16, 2014	SUPPL -43	View Letter (PDF)
Aug 13, 2012	SUPPL -42	View Letter (PDF)
Jul 5, 2011	SUPPL -39	View Letter (PDF)
May 12, 2011	SUPPL -38	View Letter (PDF)
Jan 4, 2011	SUPPL -32	View Letter (PDF)
Nov 22, 2010	SUPPL -35	View Letter (PDF)
Jun 29, 2010	SUPPL -36	View Letter (PDF)
Mar 21, 2008	SUPPL -31	View Letter (PDF)
Mar 1, 2007	SUPPL -28	View Letter (PDF)
Mar 23, 2006	SUPPL -29	View Letter (PDF)
Oct 4, 2004	SUPPL -26	View Letter (PDF)
Aug 15, 2003	SUPPL -24	View Letter (PDF)
Mar 22, 2002	SUPPL -16	View Letter (PDF)
Sep 25, 1998	SUPPL -2	View Letter (PDF)
Sep 25, 1998	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.05MG BASE/INH

RLD

0 patents0 exclusivities▴

POWDER;INHALATION | Approved: Sep 19, 1997

No patent or exclusivity listings for this strength.