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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019901
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALTACE RAMIPRIL 1.25MG CAPSULE;ORAL Prescription AB Yes No
ALTACE RAMIPRIL 2.5MG CAPSULE;ORAL Prescription AB Yes No
ALTACE RAMIPRIL 5MG CAPSULE;ORAL Prescription AB Yes No
ALTACE RAMIPRIL 10MG CAPSULE;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/26/2017 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019901s067lbl.pdf
09/11/2015 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019901s065lbl.pdf
05/02/2014 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019901s064lbl.pdf
11/04/2013 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s062lbl.pdf
10/25/2013 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s063lbl.pdf
09/23/2013 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s060lbl.pdf
04/11/2012 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019901s059lbl.pdf
08/23/2011 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019901s058lbl.pdf
10/21/2010 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019901s055lbl.pdf
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