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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207687
Company: ACCORD HLTHCARE
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
03/30/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2021 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/17/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/16/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/16/2019 SUPPL-1 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 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 214969 AUGUST
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 204846 INVAGEN PHARMS
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 204991 LUPIN LTD
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 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 LABS PVT LTD
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 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 214969 AUGUST
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 204846 INVAGEN PHARMS
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 204991 LUPIN LTD
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 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 LABS PVT LTD
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 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 214969 AUGUST
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 204846 INVAGEN PHARMS
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 204991 LUPIN LTD
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 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 LABS PVT LTD
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 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 214969 AUGUST
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 204846 INVAGEN PHARMS
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 204991 LUPIN LTD
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 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 LABS PVT LTD
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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