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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019152
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALAN SR VERAPAMIL HYDROCHLORIDE 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
CALAN SR VERAPAMIL HYDROCHLORIDE 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
CALAN SR VERAPAMIL HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/22/2020 SUPPL-45 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019152Orig1s045lbl.pdf
10/28/2019 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019152s044lbl.pdf
09/14/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019152s041lbl.pdf
08/24/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019152s039lbl.pdf
10/28/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf
12/01/2011 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf
03/31/2010 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf
07/01/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf
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