Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077691
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription AB No No
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription AB No No
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription AB No No
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription AB No No
SIMVASTATIN SIMVASTATIN 80MG 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
12/20/2006 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/31/2018 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

10/15/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

11/05/2014 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

11/05/2014 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

11/28/2012 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

04/26/2012 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

01/11/2012 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/26/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/08/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

09/18/2010 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/08/2010 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/02/2012 SUPPL-10 Labeling

Label is not available on this site.

04/03/2009 SUPPL-5 Labeling

Label is not available on this site.

06/09/2008 SUPPL-3 Labeling

Label is not available on this site.

SIMVASTATIN

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 090383 VIVA HLTHCARE
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 5MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 5MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 090383 VIVA HLTHCARE
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 10MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 10MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 090383 VIVA HLTHCARE
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 20MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 20MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 090383 VIVA HLTHCARE
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 40MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 40MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 078155 ACCORD HLTHCARE
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 077691 AUROBINDO PHARMA
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 078034 BIOCON LIMITED
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 077752 DR REDDYS LABS INC
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 200895 HETERO LABS LTD III
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 078103 LUPIN
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 078735 OXFORD PHARMS
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 090383 VIVA HLTHCARE
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 076685 WATSON LABS TEVA
SIMVASTATIN SIMVASTATIN 80MG TABLET;ORAL Prescription No AB 077837 ZYDUS PHARMS USA
ZOCOR SIMVASTATIN 80MG TABLET;ORAL Prescription Yes AB 019766 MSD MERCK CO

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