Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019684
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCARDIA XL NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
PROCARDIA XL NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
PROCARDIA XL NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/06/1989 ORIG-1 Approval Type 3 - New Dosage Form 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
01/09/2015 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019684s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019684Orig1s029ltr.pdf
06/05/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/06/2014 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019684s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019684Orig1s027ltr.pdf
07/25/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019684s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019684Orig1s026ltr.pdf
09/27/2011 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019684s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019684s024ltr.pdf
10/04/2010 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019684s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019684s023ltr.pdf
04/05/2000 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/1998 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1997 SUPPL-14 Labeling

Label is not available on this site.

04/21/1997 SUPPL-13 Labeling

Label is not available on this site.

01/08/1997 SUPPL-12 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19787-S013_Norvasc.pdf
03/29/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-10 Labeling

Label is not available on this site.

12/26/1995 SUPPL-9 Labeling

Label is not available on this site.

04/04/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/18/1991 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/14/1990 SUPPL-5 Labeling

Label is not available on this site.

05/18/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/09/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/08/1990 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/13/1989 SUPPL-1 Manufacturing (CMC)

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-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019684s029lbl.pdf
05/06/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019684s027lbl.pdf
07/25/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019684s026lbl.pdf
09/27/2011 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019684s024lbl.pdf
10/04/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019684s023lbl.pdf

PROCARDIA XL

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210614 NOVAST LABS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077127 OSMOTICA PHARM US
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210838 SPIL
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203126 TWI PHARMS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 075289 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210012 ZYDUS PHARMS
PROCARDIA XL NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019684 PFIZER

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210614 NOVAST LABS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077127 OSMOTICA PHARM US
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210838 SPIL
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203126 TWI PHARMS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 075289 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210012 ZYDUS PHARMS
PROCARDIA XL NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019684 PFIZER

TABLET, EXTENDED RELEASE;ORAL; 90MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210614 NOVAST LABS
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077127 OSMOTICA PHARM US
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210838 SPIL
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203126 TWI PHARMS
NIFEDIPINE NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210012 ZYDUS PHARMS
PROCARDIA XL NIFEDIPINE 90MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019684 PFIZER

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English