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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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/31/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018651Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/17/2023 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018651s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018651Orig1s033ltr.pdf
08/28/2017 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018651s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018651Orig1s029ltr.pdf
06/21/2006 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018651s025,s026LTR.pdf
06/21/2006 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018651s025,s026LTR.pdf
04/26/2005 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018651s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018651s021ltr.pdf
05/21/2004 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
04/28/2003 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018651s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18651slr018ltr.pdf
09/06/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
09/06/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
01/17/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
04/05/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
09/22/2000 SUPPL-13 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/018651s013lbl.pdf
06/21/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
08/05/1999 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18651S011_Marinol.pdf
10/30/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
03/05/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
12/22/1992 SUPPL-6 Efficacy-New Indication

Label is not available on this site.
03/03/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
03/31/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
03/31/1989 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
01/28/1986 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/17/2023 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018651s033lbl.pdf
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

MARINOL

CAPSULE;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DRONABINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription No AB 207421 ASCENT PHARMS INC
MARINOL DRONABINOL 2.5MG CAPSULE;ORAL Prescription Yes AB 018651 ALKEM LABS LTD

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DRONABINOL DRONABINOL 5MG CAPSULE;ORAL Prescription No AB 207421 ASCENT PHARMS INC
MARINOL DRONABINOL 5MG CAPSULE;ORAL Prescription Yes AB 018651 ALKEM LABS LTD

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DRONABINOL DRONABINOL 10MG CAPSULE;ORAL Prescription No AB 207421 ASCENT PHARMS INC
MARINOL DRONABINOL 10MG CAPSULE;ORAL Prescription Yes AB 018651 ALKEM LABS LTD
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