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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206015
Company: AUROBINDO PHARMA
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
12/20/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206015Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206015Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/11/2024 SUPPL-8 Labeling, Labeling-Package Insert

Label is not available on this site.

06/02/2023 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

06/02/2023 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/24/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/24/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206015Orig1s000lbl.pdf

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 205961 AMNEAL PHARMS NY
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 205977 HETERO LABS LTD V
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206029 LUPIN LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206070 MYLAN
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
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206047 ZYDUS PHARMS

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 205961 AMNEAL PHARMS NY
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 205977 HETERO LABS LTD V
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206029 LUPIN LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206070 MYLAN
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
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206047 ZYDUS PHARMS

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 205961 AMNEAL PHARMS NY
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 205977 HETERO LABS LTD V
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206029 LUPIN LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206070 MYLAN
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
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206047 ZYDUS PHARMS
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