Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204846
Company: INVAGEN PHARMS
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
01/09/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204846Orig1s000ltr.pdf

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

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