Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206200
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUDESONIDE BUDESONIDE 3MG CAPSULE, DELAYED RELEASE;ORAL Prescription AB 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
07/31/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2021 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.

BUDESONIDE

CAPSULE, DELAYED RELEASE;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUDESONIDE BUDESONIDE 3MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 206200 AMNEAL PHARMS
BUDESONIDE BUDESONIDE 3MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 090410 AUROBINDO PHARMA USA
BUDESONIDE BUDESONIDE 3MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 206623 MAYNE PHARMA
BUDESONIDE BUDESONIDE 3MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 207367 RISING
BUDESONIDE BUDESONIDE 3MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 209041 SCIECURE PHARMA INC
BUDESONIDE BUDESONIDE 3MG CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 206134 ZYDUS PHARMS
ENTOCORT EC BUDESONIDE 3MG CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 021324 PADAGIS US

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