Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020702
Company: UPJOHN
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIPITOR | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/17/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020702_s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/02/2024 | SUPPL-81 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020702Orig1s081ltr.pdf | |
| 12/07/2022 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020702Orig1s079correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020702Orig1s079correctedltr.pdf | |
| 09/25/2020 | SUPPL-78 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020702s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020702Orig1s078ltr.pdf | |
| 11/16/2020 | SUPPL-77 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020702s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020702Orig1s077ltr.pdf | |
| 11/27/2019 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020702s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020702Orig1s074ltr.pdf | |
| 04/12/2019 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020702s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020702Orig1s073ltr.pdf | |
| 08/10/2018 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020702s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020702Oirg1s071ltr.pdf | |
| 06/23/2017 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020702Orig1s067s069ltr.pdf | |
| 06/23/2017 | SUPPL-67 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020702Orig1s067s069ltr.pdf | |
| 03/11/2015 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020702s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020702Orig1s065ltr.pdf | |
| 05/21/2014 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020702s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020702Orig1s064ltr.pdf | |
| 10/31/2012 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702Orig1s062,s063ltr.pdf | |
| 10/31/2012 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702Orig1s062,s063ltr.pdf | |
| 11/30/2012 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702Orig1s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020702s060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020702s060.pdf | |
| 03/27/2009 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020702s057ltr.pdf | |
| 06/17/2009 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020702s056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020702Orig1s056.pdf | |
| 09/26/2007 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s050ltr.pdf | |
| 01/16/2007 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s049ltr.pdf | |
| 03/02/2007 | SUPPL-47 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020702s047ltr.pdf | |
| 06/23/2006 | SUPPL-46 | Labeling |
Letter (PDF)
Patient Package Insert (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020702s046LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020702s046Pi.pdf |
| 08/07/2006 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020702s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020702s044LTR.pdf | |
| 10/11/2005 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020702s043ltr.pdf |
| 09/21/2005 | SUPPL-42 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020702s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020702s042ltr.pdf | |
| 07/30/2004 | SUPPL-39 | Efficacy-New Indication |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20702s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020702_s039_LIPITOR_TABLETS.pdf |
| 09/29/2003 | SUPPL-37 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702scs037_lipitor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20702scs037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020702_s037_LIPITOR_TABLETS.pdf | |
| 05/12/2003 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702slr036_lipitor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20702slr036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020702_S036_LIPITOR.pdf | |
| 07/02/2002 | SUPPL-35 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020702_S035_LIPITOR.pdf |
| 04/22/2002 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702s029s034.pdf | |
| 10/18/2002 | SUPPL-33 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702se5-033ltr.pdf | |
| 04/08/2002 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/27/2001 | SUPPL-31 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020702_S031_LIPITOR.pdf |
| 12/27/2001 | SUPPL-30 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020702_S030_LIPITOR.pdf |
| 04/22/2002 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20702s029s034.pdf | |
| 11/20/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020702_S028_LIPITOR.pdf |
| 05/24/2004 | SUPPL-27 | Labeling |
Letter (PDF)
Patient Package Insert (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20702slr027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20702slr027_lipitor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020702_s027_LIPITOR_TABLETS.pdf |
| 06/08/2001 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20702s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20702S25ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-702S025_Lipitor.cfm | |
| 11/14/2000 | SUPPL-24 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020702_S024_LIPITOR_TABLETS.pdf |
| 04/07/2000 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020702_S022_LIPITOR_AP.pdf |
| 12/01/1999 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020702_S021_LIPITOR.pdf |
| 12/22/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-18 | Efficacy-New Indication |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20702S18LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020702-S018_Lipitor.cfm |
| 08/28/1998 | SUPPL-14 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702A_S014.PDF |
| 06/25/1998 | SUPPL-13 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S013_LIPITOR.pdf |
| 06/03/1998 | SUPPL-12 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S012_LIPITOR.pdf |
| 08/04/1998 | SUPPL-11 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S011_LIPITOR.pdf |
| 04/29/1998 | SUPPL-10 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S010_LIPITOR.pdf |
| 03/23/1998 | SUPPL-9 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702_S009_LIPITOR.pdf |
| 11/05/1997 | SUPPL-8 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020702_S008_LIPITOR_TABLETS_AP.pdf |
| 02/06/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1998 | SUPPL-5 | Efficacy-New Indication |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20702ltrs003s005.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20702s005.cfm |
| 02/02/1998 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020702a_s004.pdf |
| 07/10/1998 | SUPPL-3 | Efficacy-New Indication |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20702ltrs003s005.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20702s005.cfm |
| 10/28/1997 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020702a_s002.pdf |
| 07/18/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/02/2024 | SUPPL-81 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf | |
| 04/02/2024 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf | |
| 12/07/2022 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020702Orig1s079correctedlbl.pdf | |
| 11/16/2020 | SUPPL-77 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020702s077lbl.pdf | |
| 09/25/2020 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020702s078lbl.pdf | |
| 11/27/2019 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020702s074lbl.pdf | |
| 04/12/2019 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020702s073lbl.pdf | |
| 08/10/2018 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020702s071lbl.pdf | |
| 06/23/2017 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf | |
| 06/23/2017 | SUPPL-67 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020702s067s069lbl.pdf | |
| 03/11/2015 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020702s065lbl.pdf | |
| 05/21/2014 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020702s064lbl.pdf | |
| 10/31/2012 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf | |
| 10/31/2012 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702s062s063lbl.pdf | |
| 02/28/2012 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020702Orig1s060lbl.pdf | |
| 06/17/2009 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s056lbl.pdf | |
| 03/27/2009 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s057lbl.pdf | |
| 09/26/2007 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s050lbl.pdf | |
| 03/02/2007 | SUPPL-47 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s047lbl.pdf | |
| 01/16/2007 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020702s049lbl.pdf | |
| 08/07/2006 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020702s044lbl.pdf | |
| 09/21/2005 | SUPPL-42 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020702s042lbl.pdf | |
| 09/29/2003 | SUPPL-37 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702scs037_lipitor_lbl.pdf |
| 05/12/2003 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20702slr036_lipitor_lbl.pdf | |
| 10/18/2002 | SUPPL-33 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s33lbl.pdf | |
| 04/22/2002 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf | |
| 04/22/2002 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20702s29s34lbl.pdf | |
| 06/08/2001 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20702s25lbl.pdf |
LIPITOR
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 | 207687 | ACCORD HLTHCARE |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214969 | AGNITIO |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 209288 | ALKEM LABS LTD |
| 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 | 217118 | AUROBINDO PHARMA LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 216436 | BIOCON PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077575 | CHARTWELL RX |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214659 | DR REDDYS |
| 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 | 209912 | GRAVITI PHARMS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214344 | HETERO LABS LTD V |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 091624 | LANNETT CO INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214513 | LAURUS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 208480 | MACLEODS PHARMS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 217081 | MANKIND PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205945 | MICRO LABS LTD INDIA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211933 | MSN |
| 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 | 205519 | SCIEGEN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211886 | SHANDONG XINHUA |
| 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 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206536 | ZYDUS PHARMS |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020702 | UPJOHN |
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 | 207687 | ACCORD HLTHCARE |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214969 | AGNITIO |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 209288 | ALKEM LABS LTD |
| 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 | 217118 | AUROBINDO PHARMA LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 216436 | BIOCON PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077575 | CHARTWELL RX |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214659 | DR REDDYS |
| 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 | 209912 | GRAVITI PHARMS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214344 | HETERO LABS LTD V |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091624 | LANNETT CO INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214513 | LAURUS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 208480 | MACLEODS PHARMS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 217081 | MANKIND PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205945 | MICRO LABS LTD INDIA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211933 | MSN |
| 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 | 205519 | SCIEGEN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211886 | SHANDONG XINHUA |
| 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 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206536 | ZYDUS PHARMS |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020702 | UPJOHN |
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 | 207687 | ACCORD HLTHCARE |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 214969 | AGNITIO |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 209288 | ALKEM LABS LTD |
| 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 | 217118 | AUROBINDO PHARMA LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 216436 | BIOCON PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077575 | CHARTWELL RX |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 214659 | DR REDDYS |
| 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 | 209912 | GRAVITI PHARMS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 214344 | HETERO LABS LTD V |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 091624 | LANNETT CO INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 214513 | LAURUS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 208480 | MACLEODS PHARMS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 217081 | MANKIND PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205945 | MICRO LABS LTD INDIA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 211933 | MSN |
| 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 | 205519 | SCIEGEN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 211886 | SHANDONG XINHUA |
| 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 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206536 | ZYDUS PHARMS |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020702 | UPJOHN |
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 | 207687 | ACCORD HLTHCARE |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 214969 | AGNITIO |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 209288 | ALKEM LABS LTD |
| 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 | 217118 | AUROBINDO PHARMA LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 216436 | BIOCON PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 077575 | CHARTWELL RX |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 214659 | DR REDDYS |
| 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 | 209912 | GRAVITI PHARMS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 214344 | HETERO LABS LTD V |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 091624 | LANNETT CO INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 214513 | LAURUS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 208480 | MACLEODS PHARMS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 217081 | MANKIND PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 205945 | MICRO LABS LTD INDIA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 211933 | MSN |
| 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 | 205519 | SCIEGEN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 211886 | SHANDONG XINHUA |
| 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 |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 206536 | ZYDUS PHARMS |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020702 | UPJOHN |