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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018817
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALAN VERAPAMIL HYDROCHLORIDE 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
CALAN VERAPAMIL HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
CALAN VERAPAMIL HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None No No
CALAN VERAPAMIL HYDROCHLORIDE 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None No No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
09/10/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/19/2021 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018817Orig1s035Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018817Orig1s035ltr.pdf
09/14/2017 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018817s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018817Orig1s033ltr.pdf
08/24/2016 SUPPL-32 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018817Orig1s032ltr.pdf
10/25/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018817s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018817Orig1s031ltr.pdf
02/13/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
11/02/2011 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s027ltr.pdf
06/29/2011 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018817s024ltr.pdf
04/13/2010 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018817s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018817s022ltr.pdf
07/09/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018817s021ltr.pdf
01/13/1998 SUPPL-19 Labeling

Label is not available on this site.
05/14/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
02/07/1996 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/04/1994 SUPPL-16 Labeling

Label is not available on this site.
09/27/1991 SUPPL-15 Labeling

Label is not available on this site.
08/12/1991 SUPPL-14 Labeling

Label is not available on this site.
02/14/1990 SUPPL-13 Labeling

Label is not available on this site.
04/13/1988 SUPPL-12 Labeling

Label is not available on this site.
02/23/1988 SUPPL-11 Labeling

Label is not available on this site.
04/29/1987 SUPPL-10 Labeling

Label is not available on this site.
04/29/1987 SUPPL-9 Labeling

Label is not available on this site.
04/29/1987 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/23/1988 SUPPL-7 Efficacy-New Dosing Regimen

Label is not available on this site.
06/27/1986 SUPPL-6 Labeling

Label is not available on this site.
05/06/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
10/20/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
12/16/1986 SUPPL-3 Efficacy-New Indication

Label is not available on this site.
06/04/1985 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/19/2021 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018817Orig1s035Lbl.pdf
09/14/2017 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018817s033lbl.pdf
10/25/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018817s031lbl.pdf
11/02/2011 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s027lbl.pdf
06/29/2011 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018817s024lbl.pdf
04/13/2010 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018817s022lbl.pdf
07/09/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf
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