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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019614
Company: AZURITY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERELAN VERAPAMIL HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
VERELAN VERAPAMIL HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
VERELAN VERAPAMIL HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
VERELAN VERAPAMIL HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/01/2019 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019614s056lbl.pdf
11/18/2016 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019614s053lbl.pdf
10/09/2014 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf
11/14/2011 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf
03/30/2010 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019614s045lbl.pdf
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