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Abbreviated New Drug Application (ANDA): 204726
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription AB No No
SILODOSIN SILODOSIN 8MG CAPSULE;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
03/31/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204726Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2021 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

SILODOSIN

CAPSULE;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAFLO SILODOSIN 4MG CAPSULE;ORAL Prescription Yes AB 022206 ALLERGAN
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 211060 AJANTA PHARMA LTD
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 209745 AMNEAL PHARMS CO
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 210626 AUROBINDO PHARMA LTD
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 204793 HETERO LABS LTD V
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 206541 LUPIN LTD
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 211166 MACLEODS PHARMS LTD
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 210687 MSN
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 209029 PRINSTON INC
SILODOSIN SILODOSIN 4MG CAPSULE;ORAL Prescription No AB 204726 SANDOZ INC

CAPSULE;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAFLO SILODOSIN 8MG CAPSULE;ORAL Prescription Yes AB 022206 ALLERGAN
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 211060 AJANTA PHARMA LTD
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 209745 AMNEAL PHARMS CO
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 210626 AUROBINDO PHARMA LTD
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 204793 HETERO LABS LTD V
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 206541 LUPIN LTD
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 211166 MACLEODS PHARMS LTD
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 210687 MSN
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 209029 PRINSTON INC
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 204726 SANDOZ INC
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