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BECONASE

NDA

BECLOMETHASONE DIPROPIONATE | N018584 | GLAXOSMITHKLINE

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 DMFs10 inactive

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

TAPI NL BVBECLOMETHASONE DIPROPIONATE

DMF 48711983

FARMABIOS SPABECLOMETHASONE DIPROPIONATE

DMF 128131998

AMPHASTAR NANJING PHARMACEUTICALS INCBECLOMETHASONE DIPROPIONATE

DMF 278372014

SYMBIOTEC PHARMALAB PRIVATE LTDBECLOMETHASONE DIPROPIONATE USP (MICRONIZED & NON-MICRONIZED)

DMF 281372014

CIPLA LTDBECLOMETHASONE DIPROPIONATE USP (ANHYDROUS)

DMF 289282015

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 60841985

QUATRUMInactiveBECLOMETHASONE DIPROPIONATE

DMF 75011988

ROUSSELL UCLAFInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 80361989

FARMABOISInactiveBECLOMETHASONE DIPROPIONATE

DMF 80761989

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveBECLOMETHASONE DIPROPIONATE MONOHYDRATE

DMF 139651999

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveBECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE

DMF 169342003

CIPLA LTDInactiveBECLOMETHASONE DIPROPIONATE

DMF 197502006

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 226482008

ALP PHARM BEIJING CO LTDInactiveBECLOMETHASONE DIPROPIONATE

DMF 230302009

HOVIONE FARMACIENCIA SAInactiveBECLOMETHASONE DIPROPIONATE MONOHYDRATE USP

DMF 271962013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 16, 2002	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.042MG/INH

0 patents0 exclusivities▴

AEROSOL, METERED;NASAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.