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BUDESONIDE

ANDA

BUDESONIDE | A205457 | ACTAVIS LABORATORIES FL INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: UCERIS(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
COSMO TECHNOLOGIES LIMITED et al v. ACTAVIS LABORATORIES FL, INC. 2:2015cv01312 5 patentsANDA 205457budesonide	D.N.J.	2015-02-19	Terminated 2015-04-20	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain25 active DMFs4 inactive

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

ASPEN OSS BVBUDESONIDE

DMF 104931993

TAPI NL BVBUDESONIDE

DMF 109761994

TAPI NL BVBUDESONIDE

DMF 169322003

FARMABIOS SPABUDESONIDE

DMF 189102005

CURIA SPAIN SAUBUDESONIDE STERILE MICRONIZED

DMF 195282006

INDUSTRIALE CHIMICA SRLBUDESONIDE USP

DMF 200102006

AARTI PHARMALABS LTDBUDESONIDE USP

DMF 206092007

STERLING SPABUDESONIDE

DMF 226412009

NEWCHEM SPABUDESONIDE MICRONIZED

DMF 253192011

FARMABIOS SPABUDESONIDE MICRONIZED STERILE

DMF 256152011

CURIA SPAIN SAUBUDESONIDE MICRONIZED

DMF 256292011

SUN PHARMACEUTICAL INDUSTRIES LTDBUDESONIDE USP

DMF 264452013

APOTEX INCBUDESONIDE USP

DMF 274512013

CIPLA LTDBUDESONIDE USP

DMF 274612014

MINAKEMBUDESONIDE MICRONIZED

DMF 284412014

CORAL DRUGS PRIVATE LTDBUDESONIDE

DMF 305342017

TIANJIN TIANYAO PHARMACEUTICALS CO LTDBUDESONIDE USP BULK API

DMF 321952017

ASTRAZENECA PHARMACEUTICAL LPBUDESONIDE

DMF 331712018

AMPHASTAR NANJING PHARMACEUTICALS INCBUDESONIDE USP

DMF 337142019

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDBUDESONIDE

DMF 342682019

HENAN LIHUA PHARMACEUTICAL CO LTDBUDESONIDE

DMF 358592021

BREATHGREEN PHARMACEUTICAL CO LTDBUDESONIDE (MICRONIZED AND STERILE)

DMF 383732023

CHEMO IBERICA SABUDESONIDE MICRONIZED STERILE

DMF 395042024

BREATHGREEN PHARMACEUTICAL CO LTDBUDESONIDE (MICRONIZED AND NON-MICRONIZED)

DMF 396912024

AURISCO PHARMACEUTICAL CO LTDBUDESONIDE

DMF 412332025

FARMABIOS SRLInactiveBUDESONIDE

DMF 130131998

FARMABIOS SPAInactiveBUDESONIDE

DMF 152982001

ELAN PHARMACEUTICAL TECHNOLOGIESInactiveBUDESONIDE NANOCRISTAL COLLOIDAL DISPERSION

DMF 156622001

INDUSTRIALE CHIMICA SRLInactiveBUDESONIDE

DMF 158772002

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 9MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 3, 2018

No patent or exclusivity listings for this strength.