Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204867
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 1MG TABLET, DELAYED RELEASE;ORAL Prescription AB No No
PREDNISONE PREDNISONE 2MG TABLET, DELAYED RELEASE;ORAL Prescription AB No No
PREDNISONE PREDNISONE 5MG TABLET, 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
04/25/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

PREDNISONE

TABLET, DELAYED RELEASE;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 1MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 204867 ACTAVIS LABS FL INC
RAYOS PREDNISONE 1MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 202020 HORIZON PHARMA USA

TABLET, DELAYED RELEASE;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 204867 ACTAVIS LABS FL INC
RAYOS PREDNISONE 2MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 202020 HORIZON PHARMA USA

TABLET, DELAYED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 5MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 204867 ACTAVIS LABS FL INC
RAYOS PREDNISONE 5MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 202020 HORIZON PHARMA USA

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