Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200895
Company: HETERO LABS LTD III
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
11/25/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2015 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/05/2015 SUPPL-1 Labeling-Package Insert

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English