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FORADIL CERTIHALER

NDA

FORMOTEROL FUMARATE | N021592 | 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 Chain13 active DMFs4 inactive

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

INKE SAFORMOTEROL FUMARATE

DMF 166282003

MATRIX PHARMACORP PRIVATE LTDFORMOTEROL FUMARATE DIHYDRATE USP

DMF 192022006

CIPLA LTDFORMOTEROL FUMARATE USP

DMF 201782007

INDUSTRIALE CHIMICA SRLFORMOTEROL FUMARATE DIHYDRATE USP

DMF 201992007

TAPI NL BVFORMOTEROL FUMARATE DIHYDRATE

DMF 213572008

LUSOCHIMICA SPAFORMOTEROL FUMARATE DIHYDRATE

DMF 238482010

MSN LABORATORIES PRIVATE LTDFORMOTEROL FUMARATE USP [ROUTE CODE "FL"]

DMF 280112014

CORAL DRUGS PRIVATE LTDFORMOTEROL FUMARATE DIHYDRATE

DMF 303242016

FARMABIOS SPAFORMOTEROL FUMARATE

DMF 329362018

AMPHASTAR NANJING PHARMACEUTICALS INCFORMOTEROL FUMARATE USP

DMF 339132019

FERMION OYFORMOTEROL FUMARATE

DMF 338942019

MELODY HEALTHCARE PVT LTDFORMOTEROL FUMARATE

DMF 413172025

VAMSI LABS LTDFORMOTEROL FUMARATE DIHYDRATE USP

DMF 428102025

ASTELLAS PHARMA INCInactiveFORMOTEROL FUMARATE

DMF 123801997

INDUSTRIALE CHIMICA SRLInactiveFORMOTEROL FUMARATE DIHYDRATE MICRONIZED

DMF 141541999

SICOR SWISS BRANCHInactiveFORMOTEROL FUMARATE

DMF 162412002

VAMSI LABS LTDInactiveFORMOTEROL FUMARATE DIHYDRATE EP

DMF 404502024

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 3, 2010	SUPPL -3	View Letter (PDF)
Dec 28, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.0085MG/INH

0 patents0 exclusivities▴

POWDER;INHALATION | Approved: Dec 15, 2006

No patent or exclusivity listings for this strength.