Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205955
Company: SAWAI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription AB No No
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription AB No No
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;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
02/03/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

PITAVASTATIN CALCIUM

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIVALO PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription Yes AB 022363 KOWA CO
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 205932 ORIENT PHARMA CO LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 205955 SAWAI USA

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIVALO PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription Yes AB 022363 KOWA CO
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 205932 ORIENT PHARMA CO LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 205955 SAWAI USA

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIVALO PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription Yes AB 022363 KOWA CO
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 205932 ORIENT PHARMA CO LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 205955 SAWAI USA

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