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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018651
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MARINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription AB Yes No
MARINOL DRONABINOL 5MG CAPSULE;ORAL Prescription AB Yes Yes
MARINOL DRONABINOL 10MG CAPSULE;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/28/2017 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018651s029lbl.pdf
06/21/2006 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf
06/21/2006 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf
04/26/2005 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018651s021lbl.pdf
04/28/2003 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018651s018lbl.pdf
09/22/2000 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/018651s013lbl.pdf
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