Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202644
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription AB No No
NIFEDIPINE NIFEDIPINE 20MG CAPSULE;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
04/25/2013 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/11/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

12/11/2014 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

NIFEDIPINE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 072579 ACTAVIS ELIZABETH
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 202644 HERITAGE PHARMA
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 072781 INTERGEL PHARM
NIFEDIPINE NIFEDIPINE 10MG CAPSULE;ORAL Prescription No AB 073250 LEADING PHARMA LLC
PROCARDIA NIFEDIPINE 10MG CAPSULE;ORAL Prescription Yes AB 018482 PFIZER

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 20MG CAPSULE;ORAL Prescription No AB 072556 ACTAVIS ELIZABETH
NIFEDIPINE NIFEDIPINE 20MG CAPSULE;ORAL Prescription No AB 202644 HERITAGE PHARMA
NIFEDIPINE NIFEDIPINE 20MG CAPSULE;ORAL Prescription No AB 074045 LEADING PHARMA LLC

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