Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075896
Company: SUN PHARM INDUSTRIES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;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
11/02/2004 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75896ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075896_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/13/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
02/13/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

FELODIPINE

TABLET, EXTENDED RELEASE;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203417 AUROBINDO PHARMA LTD
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090365 GLENMARK GENERICS
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201964 HERITAGE PHARMS INC
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203983 JUBILANT GENERICS
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203032 ORCHID HLTHCARE
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091200 SUN PHARM INDS LTD
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075896 SUN PHARM INDUSTRIES
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202170 TORRENT PHARMS LTD
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200815 VINTAGE PHARMS LLC
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210847 YILING
FELODIPINE FELODIPINE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204800 YUNG SHIN PHARM

TABLET, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203417 AUROBINDO PHARMA LTD
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090365 GLENMARK GENERICS
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201964 HERITAGE PHARMS INC
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203983 JUBILANT GENERICS
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203032 ORCHID HLTHCARE
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091200 SUN PHARM INDS LTD
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075896 SUN PHARM INDUSTRIES
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202170 TORRENT PHARMS LTD
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200815 VINTAGE PHARMS LLC
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210847 YILING
FELODIPINE FELODIPINE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204800 YUNG SHIN PHARM

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203417 AUROBINDO PHARMA LTD
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090365 GLENMARK GENERICS
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201964 HERITAGE PHARMS INC
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203983 JUBILANT GENERICS
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203032 ORCHID HLTHCARE
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091200 SUN PHARM INDS LTD
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075896 SUN PHARM INDUSTRIES
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202170 TORRENT PHARMS LTD
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200815 VINTAGE PHARMS LLC
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210847 YILING
FELODIPINE FELODIPINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204800 YUNG SHIN PHARM

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