Viewing data from:

AEROSPAN HFA

NDA

FLUNISOLIDE | N021247 | PHARMOBEDIENT CONSULTING LLC

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 Chain5 active DMFs6 inactive

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

TAPI NL BVFLUNISOLIDE ANHYDROUS

DMF 115741995

FARMABIOS SPAFLUNISOLIDE ANHYDROUS USP

DMF 194772006

STERLING SPAFLUNISOLIDE ANHYDROUS

DMF 203752007

TAPI NL BVFLUNISOLIDE ANHYDROUS (NEW PROCESS)

DMF 227722009

FARMABIOS SPAFLUNISOLIDE HEMIHYDRATE (MICRONIZED)

DMF 261482012

DR REDDYS LABORATORIES LTDInactiveFLUNISOLIDE

DMF 31451978

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveFLUNISOLIDE HEMIHYDRATE

DMF 47741982

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveFLUNISOLIDE

DMF 68111987

NOBEL CHEMS SPAInactiveFLUNISOLIDE

DMF 84591990

FARMABOISInactiveFLUNISOLIDE

DMF 85661990

DR REDDYS LABORATORIES LTDInactiveFLUNISOLIDE HEMIHYDRATE

DMF 169352003

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2018	SUPPL -17	View Letter (PDF)
Nov 27, 2017	SUPPL -16	View Letter (PDF)
Jun 27, 2017	SUPPL -15	View Letter (PDF)
Aug 29, 2013	SUPPL -8	View Letter (PDF)
Nov 19, 2012	SUPPL -7	View Letter (PDF)
Feb 2, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.078MG/INH

RLD

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Jan 27, 2006

No patent or exclusivity listings for this strength.