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Abbreviated New Drug Application (ANDA): 205519
Company: SCIEGEN PHARMS 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
05/19/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205519Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2023 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

10/25/2022 SUPPL-28 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/27/2021 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

05/27/2021 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

07/01/2020 SUPPL-21 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/21/2019 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

10/21/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

10/21/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/21/2019 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/21/2019 SUPPL-6 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 207687 ACCORD HLTHCARE
ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 217634 ACI
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 212103 CADILA PHARMS LTD
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 204991 LUPIN 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 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 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 213853 UMEDICA
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 217634 ACI
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 212103 CADILA PHARMS LTD
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 204991 LUPIN 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 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 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 213853 UMEDICA
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 217634 ACI
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 212103 CADILA PHARMS LTD
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 204991 LUPIN 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 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 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 213853 UMEDICA
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 217634 ACI
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 212103 CADILA PHARMS LTD
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 204991 LUPIN 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 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 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 213853 UMEDICA
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
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