FDA.report

Application 020929

Type
NDA
Sponsor
ASTRAZENECA PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION0.25MG/2MLYesNo
002PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION0.5MG/2MLYesNo
003PULMICORT RESPULESBUDESONIDESUSPENSION;INHALATION1MG/2MLYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-1988PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1988PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1988PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1988PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1989PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1989PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1989PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1989PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1990PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1990PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1990PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent
0186-1990PULMICORT RESPULESBudesonideAstraZeneca Pharmaceuticals LPNDACurrent

Documents

DocumentSubmission typeDate
59950SUPPL2019-09-10
59937SUPPL2019-09-09
26216SUPPL2010-07-23
13753SUPPL2010-07-06
3767SUPPL2009-11-10
13752SUPPL2009-10-14
26215SUPPL2007-07-05
41817SUPPL2007-04-11
21280SUPPL2007-04-11
3764SUPPL2006-07-21
3766SUPPL2005-07-08
21279ORIG2004-02-11
13751SUPPL2003-09-30
26214SUPPL2003-09-26
26213SUPPL2003-03-10
35656SUPPL2003-02-26
3765SUPPL2003-01-10
35655ORIG2000-08-08
26212ORIG2000-08-08
51795ORIG1900-01-01
51794ORIG1900-01-01
51793ORIG1900-01-01
51792ORIG1900-01-01
51791ORIG1900-01-01
51790ORIG1900-01-01
51789ORIG1900-01-01