Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090548
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription AB No No
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription AB No No
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription AB No No
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG 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
05/29/2012 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090548Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/28/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/06/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

ATORVASTATIN CALCIUM

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 090548 APOTEX INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 091650 DR REDDYS LABS LTD
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 204846 INVAGEN PHARMS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 091624 KREMERS URBAN PHARMS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 091226 MYLAN PHARMS INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 077575 SANDOZ INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 205519 SCIEGEN PHARMS INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 076477 SUN PHARM INDS LTD
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 205300 TEVA PHARMS USA
LIPITOR ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription Yes AB 020702 PFIZER

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 090548 APOTEX INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 091650 DR REDDYS LABS LTD
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 204846 INVAGEN PHARMS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 091624 KREMERS URBAN PHARMS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 091226 MYLAN PHARMS INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 077575 SANDOZ INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 205519 SCIEGEN PHARMS INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 076477 SUN PHARM INDS LTD
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription No AB 205300 TEVA PHARMS USA
LIPITOR ATORVASTATIN CALCIUM EQ 20MG BASE TABLET;ORAL Prescription Yes AB 020702 PFIZER

TABLET;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 090548 APOTEX INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 091650 DR REDDYS LABS LTD
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 204846 INVAGEN PHARMS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 091624 KREMERS URBAN PHARMS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 091226 MYLAN PHARMS INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 077575 SANDOZ INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 205519 SCIEGEN PHARMS INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 076477 SUN PHARM INDS LTD
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription No AB 205300 TEVA PHARMS USA
LIPITOR ATORVASTATIN CALCIUM EQ 40MG BASE TABLET;ORAL Prescription Yes AB 020702 PFIZER

TABLET;ORAL; EQ 80MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 090548 APOTEX INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 202357 DR REDDYS LABS LTD
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 204846 INVAGEN PHARMS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 091624 KREMERS URBAN PHARMS
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 091226 MYLAN PHARMS INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 077575 SANDOZ INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 205519 SCIEGEN PHARMS INC
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 076477 SUN PHARM INDS LTD
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription No AB 205300 TEVA PHARMS USA
LIPITOR ATORVASTATIN CALCIUM EQ 80MG BASE TABLET;ORAL Prescription Yes AB 020702 PFIZER

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