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BUDESONIDE از شرکت TEVA PHARMS

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BUDESONIDE از شرکت TEVA PHARMS

Abbreviated New Drug Application (ANDA): 077519

Company: TEVA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription

AN

No No
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription

AN

No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/18/2008 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077519s000ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/31/2021 SUPPL-14 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

06/03/2015 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

10/14/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/23/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

BUDESONIDE

SUSPENSION;INHALATION; 0.25MG/2ML

TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 205710 CIPLA
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 078404 IMPAX LABS INC
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 078202 NEPHRON
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 201966 SANDOZ INC
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 211922 SUN PHARM
BUDESONIDE BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription No AN 077519 TEVA PHARMS
PULMICORT RESPULES BUDESONIDE 0.25MG/2ML SUSPENSION;INHALATION Prescription Yes AN 020929 ASTRAZENECA

SUSPENSION;INHALATION; 0.5MG/2ML

TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 205710 CIPLA
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 078404 IMPAX LABS INC
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 210897 LUPIN
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 078202 NEPHRON
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 201966 SANDOZ INC
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 211922 SUN PHARM
BUDESONIDE BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription No AN 077519 TEVA PHARMS
PULMICORT RESPULES BUDESONIDE 0.5MG/2ML SUSPENSION;INHALATION Prescription Yes AN 020929 ASTRAZENECA
حتما بخوانید : BUDESONIDE از شرکت IMPAX LABS INC
بخوانید  CONSTULOSE از شرکت ACTAVIS MID ATLANTIC
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