Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211166
Company: MACLEODS PHARMS LTD
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
12/03/2018 ORIG-1 Approval STANDARD

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 SALES LLC
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 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 LABS PVT LTD
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 SALES LLC
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 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 LABS PVT LTD
SILODOSIN SILODOSIN 8MG CAPSULE;ORAL Prescription No AB 204726 SANDOZ INC

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