Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018482
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCARDIA NIFEDIPINE 10MG CAPSULE;ORAL Prescription AB Yes Yes
PROCARDIA NIFEDIPINE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
12/31/1981 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/2015 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018482s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018482Orig1s052ltr.pdf
07/25/2013 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018482Orig1s051ltr.pdf
09/27/2011 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018482s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018482s049ltr.pdf
04/05/2000 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/2002 SUPPL-43 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18482s43ltr.pdf
08/12/1997 SUPPL-42 Labeling

Label is not available on this site.

04/21/1997 SUPPL-41 Labeling

Label is not available on this site.

03/22/1996 SUPPL-40 Labeling

Label is not available on this site.

03/29/1996 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/28/1995 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1995 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1994 SUPPL-36 Labeling

Label is not available on this site.

10/04/1995 SUPPL-35 Labeling

Label is not available on this site.

04/04/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/09/1992 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1990 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/09/1990 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/05/1988 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1988 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/13/1988 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1987 SUPPL-27 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/03/1987 SUPPL-26 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/04/1995 SUPPL-25 Labeling

Label is not available on this site.

09/17/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/26/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/26/1985 SUPPL-21 Labeling

Label is not available on this site.

08/26/1985 SUPPL-19 Labeling

Label is not available on this site.

05/30/1985 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1985 SUPPL-17 Labeling

Label is not available on this site.

11/20/1984 SUPPL-15 Efficacy

Label is not available on this site.

11/20/1984 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/24/1986 SUPPL-12 Efficacy-New Dosing Regimen

Label is not available on this site.

03/22/1984 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/24/1986 SUPPL-10 Labeling

Label is not available on this site.

04/06/1984 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/23/1983 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1983 SUPPL-6 Labeling

Label is not available on this site.

03/10/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/10/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/07/1983 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/17/1982 SUPPL-2 Labeling

Label is not available on this site.

08/06/1982 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/09/2015 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018482s052lbl.pdf
07/25/2013 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018482s051lbl.pdf
09/27/2011 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018482s049lbl.pdf

PROCARDIA

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

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